NIV: Coronary Covered Stent
FDA product code NIV. HDE. What the classification flags say about Part 820 under the QMSR.
As of Nov 2, 2026, FDA product code NIV (Coronary Covered Stent) is HDE, reviewed through HDE (Humanitarian Device Exemption), with 0 linked 510(k), De Novo or BK numbers, 0 PMAs and 0 recall product records.
Classification
- Product code
- NIV
- Device name
- Coronary Covered Stent
- Device class
- HDE
- Regulation
- FDA lists no classification regulation for this code
- Review panel
- Cardiovascular
- Premarket route
- HDE (Humanitarian Device Exemption)
- CGMP-exempt flag
- No
- Life-sustaining flag
- Yes
- Implant flag
- Yes
- Third-party review
- Not a candidate
- Summary malfunction reporting
- Eligible
FDA definition. Stent, coronary, covered -- a metal scaffold covered with material placed via a delivery catheter into the coronary artery artery or saphenous vein graft for the treatment of free perforations and/or to prevent dislodgement into the circulation of biological material from the vascular wall during or following placement of the device.
Data from openFDA as of 2 November 2026. Read the record on openFDA · FDA product code classification database
Part 820 requirements the flags point to
Part 820 rules for NIV
- CGMP exemptionClassification regulation, 21 CFR parts 862 to 892
- Not flaggedFDA does not flag this product code as exempt.A manufacturer of a finished device of this type falls under part 820 (21 CFR 820.1(a)). Some classification regulations exempt only part of a generic device type, so read the regulation for your device.FDA: QMSR, CGMP exemptions · 21 CFR 820.35
- Design and development, ISO 13485 clause 7.321 CFR 820.10(c)
- Database cannot sayFDA lists the class as HDE.820.10(c) names class II, class III and listed class I devices. The database does not give one of those classes for an HDE code. Read the rule against the device's approved status.21 CFR 820.10
- Traceability, ISO 13485 clause 7.5.9.221 CFR 820.10(d)
- Flag points to the ruleFDA flags this code as life-supporting or life-sustaining.The flag uses the definition in 21 CFR 860.3, which FDA says explains the phrase "support or sustain life" in 820.10(d). The rule adds a condition the flag cannot carry: failure to perform when properly used must reasonably be expected to result in a significant injury. The manufacturer decides that for its device. The code is also flagged as an implant.21 CFR 820.10 · 21 CFR 860.3 · QMSR final rule, comment 49
- Complaint and record content21 CFR 820.35
- Rule names this classApplies to every finished-device manufacturer, exempt or not.820.35 adds content to complaint records, servicing records and UDI recording on top of ISO 13485 clause 4.2.5. FDA says CGMP exemption does not lift these records.21 CFR 820.35 · FDA: QMSR, CGMP exemptions
These flags describe the classification of a product code. They are not a determination for a specific device or manufacturer. How a manufacturer meets 21 CFR 820.10 depends on its own device, its intended use and the full text of the rule.
Clearances and recalls on record
- 510(k), De Novo and BK numbers linked
- 0
- PMA numbers linked
- 0
- Recall product records
- 0
- Adverse event reports
- Search MAUDE for NIV
Recall records count products, and one recall event can add many. Counts show activity in a category. They do not measure its safety.
Search all 7,098 product codes, or read the guide to the Part 820 rules behind these flags.
Check your quality documents against Part 820
Arca puts your SOPs and design files in a library and compares them against the Part 820 requirements for your device in a grid, one row per document and one column per requirement, with each cell cited to its source.