NIQ: Coronary Drug-Eluting Stent

FDA product code NIQ. Class III. What the classification flags say about Part 820 under the QMSR.

Classification

Product code: NIQ
Device name: Coronary Drug-Eluting Stent
Device class: Class III
Regulation: FDA lists no classification regulation for this code
Review panel: Cardiovascular
Premarket route: PMA
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, drug-eluting -- a metal scaffold with a drug coating placed via a delivery catheter into the coronary artery or saphenous vein graft to maintain the lumen. The drug coating is intended to inhibit restenosis.

Data from openFDA as of 26 October 2026. Read the record on openFDA · FDA product code classification database

Part 820 requirements the flags point to

Part 820 rules for NIQ

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): Rule names this classRule names Class III.21 CFR 820.10(c) requires manufacturers of class II and class III devices to comply with clause 7.3 and its subclauses.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: 16
Recall product records: 6
Adverse event reports: Search MAUDE for NIQ

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 7,097 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.