510(k) Report

FDA applicant

Possis Medical, Inc.

Minneapolis, MN35 decisions1983–20146 recalls

FDA records 35 decisions for Possis Medical, Inc. (Minneapolis, MN) from 1983 to 2014: 34 510(k) clearances and 1 original PMA approval. Most are in product codes QEZ (Aspiration Thrombectomy Catheter) and DTB (Permanent Pacemaker Electrode). Its devices cite 60 predicates, 48 of them its own earlier devices. 6 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 Possis Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2007: 62008: 52009: 22014: 1
2007high 6 (2007) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

2in 2015

2007: 22009: 12015: 2
2007high 2 (2007) · low 0 (2008)2026

Class I Class II/III not classified

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

Planning a device like Possis Medical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • QEZAspiration Thrombectomy Catheter19decisions
  • DTBPermanent Pacemaker Electrode5decisions
  • MJNCatheter, Intravascular Occluding, Temporary3decisions
  • MCWCatheter, Peripheral, Atherectomy2decisions
  • DSYProsthesis, Vascular Graft, Of 6mm And Greater Diameter1decision
  • QEWPeripheral Mechanical Thrombectomy With Aspiration1decision

Also: DWF (1), DTD (1), DYF (1).

Whose devices does it build on?

Its devices cite 60 predicates; 48 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 59 times; 48 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.

  • K960970Possis Angiojet Rapid Thrombectomy Catheter System, F105 Catheter,Model 3030C,LF140 Catheter,Model…Possis Medical, Inc. · 19967cite it
  • K052256Angiojet Xpeedior 120 CatheterPossis Medical, Inc. · 20056cite it
  • K972610Possis Angiojet Rapid Thombectomy Catheters--F105 Catheter Model 3030C, LF140 Catheter Model 3040CPossis Medical, Inc. · 20006cite it
  • K040013Angiojet Xpeedior 120 Catheter and Angiojet Power Pulse Spray Ancillary KitPossis Medical, Inc. · 20045cite it
  • K993564Possis Angiojet X-Stream Rheolytic Thrombectomy Catheter, Model 103587-002Possis Medical, Inc. · 20005cite it
  • K061951Angiojet Xpeedior Rheolytic Thrombectomy Catheter, Model Xpeedior 120Possis Medical, Inc. · 20064cite it

What has FDA decided for it lately?

  • K133629Angiojet Ultra Avx Thrombectomy SetPossis Medical, Inc. · 20141 recall
  • K091593Angio Jet Ultra DVX and Xpeedior Thrombectomy SetsPossis Medical, Inc. · 2009
  • K090253Angiojet Ultra DVX Thrombectomy Set, Model 106552-001, Angiojet Ultra Xpeedior Thrombectomy Set, Model…Possis Medical, Inc. · 2009
  • K082382Angiojet Ultra Avx Thrombectomy Set, Model 105039Possis Medical, Inc. · 2008
  • K081989Modification to Fetch Aspiration CatheterPossis Medical, Inc. · 2008
  • K081454Guarddog Occlusion Guidewire, Inflation DevicePossis Medical, Inc. · 2008
  • K080806Angiojet Ultra Spiroflex VG Thrombectomy Set, Model 106608Possis Medical, Inc. · 2008
  • K073441Angiojet Ultra Avx Thrombectomy Set, Model 105039Possis Medical, Inc. · 2008

All 35 as Possis Medical, Inc. →

What has been recalled?

6 recalls linked to its devices; the latest:

  • K133629AngioJet AVX Thrombectomy Set: UPN 105039-001, Catalog No.105039, Sterilized Using…Jul 31, 2015Class II
  • K072769AngioJet Spiroflex Thrombectomy Set: Peripheral - UPN 106553-004, Catalog No.106553…Jul 31, 2015Class II
  • K925099Enpath Myopore Sutureless Myocardial Pacing Lead, Ref: 511211. the contents of the inner…Sep 1, 2009
  • K050794Possis AngioJet XVG Thrombectomy Sets, Model/Order # 105042-001, Sterilized with…Jun 19, 2007
  • K042874Angiojet XMI Rapid Exchange, catheters, 135 cm, 4 F, Single Use Only, Sterilized with…May 1, 2007
  • K042874AngioJet XMI Rapid Exchange +, 4F, 135 cm. Contents: One (1) Thrombectomy Catheter for…Dec 12, 2005