510(k) Report

FDA applicant

Bridgepoint Medical

Plymouth, MN14 decisions2008–20122 recalls

FDA records 14 decisions for Bridgepoint Medical (Plymouth, MN) from 2008 to 2012: 14 510(k) clearances. Most are in product codes DQY (Catheter, Percutaneous) and DQX (Wire, Guide, Catheter). Its devices cite 29 predicates, 17 of them its own earlier devices. 2 recalls are 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 Bridgepoint Medical’s devices, and how often a recall has named them.

FDA decisions per year

6in 2012

2008: 12009: 42010: 12011: 22012: 6
2008high 6 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

1in 2018

2012: 12018: 1
2008high 1 (2012) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Bridgepoint Medical by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DQYCatheter, Percutaneous7decisions
  • DQXWire, Guide, Catheter6decisions
  • PDUCatheter For Crossing Total Occlusions1decision

Whose devices does it build on?

Its devices cite 29 predicates; 17 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 27 times; 17 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.

  • K080987Bridgepoint Medical Stingray Device and AccessoriesBridgepoint Medical · 20094cite it
  • K120533Bigboss Catheters Mantatay Catheter Mantaray GuidewiresBridgepoint Medical · 20124cite it
  • K081187Bridgepoint Medical Entera Percutaneous Coronary and Peripheral Guidewire, Model M-3001Bridgepoint Medical · 20083cite it
  • K081130Bridgepoint Medical Crossboss Percutaneous Coronary CatheterBridgepoint Medical · 20093cite it
  • K101591Stingray Orienting Balloon CatheterBridgepoint Medical · 20102cite it
  • K111963Bridgepoint Medical Mantaray (TM) CatheterBridgepoint Medical · 20112cite it

What has FDA decided for it lately?

  • K122795Stingray GuidewiresBridgepoint Medical · 20121 recall
  • K121745Mantaray GuidewiresBridgepoint Medical · 2012
  • K120533Bigboss Catheters Mantatay Catheter Mantaray GuidewiresBridgepoint Medical · 2012
  • K120881Mantaray GuidewiresBridgepoint Medical · 2012
  • K120129Mantaray CatheterBridgepoint Medical · 2012
  • K113589Bigboss CatheterBridgepoint Medical · 2012
  • K111963Bridgepoint Medical Mantaray (TM) CatheterBridgepoint Medical · 2011
  • K111488Mantaray Guidewire Model M-6000, M-6001, M-6002, M-6003Bridgepoint Medical · 2011

All 14 as Bridgepoint Medical →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K122795Stingray" Guidewire, labeled as 300cm. intended to facilitate placement of balloon…Dec 19, 2018Class II
  • K080987BridgePoint Medical, Stingray Catheter, REF M - 1000, Sterilized with Ethylene Oxide…Jun 26, 2012Class II