Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Mallinckroot, Inc. with 7 510(k) clearances. The most recent is a 510(k) clearance dated Apr 16, 1999: COPPERHEAD 5 FR. PTA CATHETER, FINCH 4 FR. PTA CATHETER.
| Date | Record | Source |
|---|---|---|
| Apr 16, 1999 | COPPERHEAD 5 FR. PTA CATHETER, FINCH 4 FR. PTA CATHETERK983830 · LIT | 510(k) clearances |
| Oct 2, 1989 | MODIFIED SOFTOUCH INTRODUCER W/HEMO VALVE & SIDEK894445 · DYB | 510(k) clearances |
| May 15, 1989 | A-V(TM) SOFTOUCH UHF CARDIAC PIGTAILK885348 · DQO | 510(k) clearances |
| Mar 14, 1989 | ATTACHABLE LANZ (TENTATIVE)K885216 · BSK | 510(k) clearances |
| Feb 22, 1989 | SOFTOUCH INTRODUCER W/HEMOSTASIS VALVE & SIDEPORTK884159 · DYB | 510(k) clearances |
| Jan 10, 1989 | CLEAR SHOT ANGIOPLASTY BALLOON INFLATION DEVICEK884481 · LIT | 510(k) clearances |
| Aug 9, 1988 | FOLEY-TEMP(TM)K882130 · EYB | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
