510(k) Report

FDA applicant

Appriva Medical, Inc.

Sunnyvale, CA2 decisions2001–20010 recalls

FDA records 2 decisions for Appriva Medical, Inc. (Sunnyvale, CA) in 2001: 2 510(k) clearances. All are in product code DYB (Introducer, Catheter). Its devices cite 1 predicate, 1 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Appriva Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Appriva Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Appriva Medical, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DYBIntroducer, Catheter2decisions

Who builds on its devices?

Later devices cite its devices 3 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K002054X-Sept Transseptal Sheath and Transition Catheter, Model MV-03-09-90, MV-03-10-90, MV-03-11-90…Appriva Medical, Inc. · 20012cite it
  • K012489Modification to: X-Sept Transseptal Shealth and Transition Catheter (with Dilator), Models PL-12-12-09…Appriva Medical, Inc. · 20011cites it

What has FDA decided for it lately?

  • K012489Modification to: X-Sept Transseptal Shealth and Transition Catheter (with Dilator), Models PL-12-12-09…Appriva Medical, Inc. · 2001
  • K002054X-Sept Transseptal Sheath and Transition Catheter, Model MV-03-09-90, MV-03-10-90, MV-03-11-90…Appriva Medical, Inc. · 2001

All 2 as Appriva Medical, Inc. →