Possis Medical, Inc.: FDA clearances and approvals
Possis Medical, Inc. has 34 FDA 510(k) clearances (first 1983, latest 2014), plus 1 PMA decision, across 10 product codes in 1 review panel. Median 510(k) review time: 72 days. openFDA lists 4 product recalls by a recalling firm named Possis Medical, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 1 | 80 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QEZ | Aspiration Thrombectomy Catheter | 19 | 19 |
| DTB | Permanent Pacemaker Electrode | 5 | 5 |
| MJN | Catheter, Intravascular Occluding, Temporary | 3 | 3 |
| MCW | Catheter, Peripheral, Atherectomy | 2 | 2 |
| DSY | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter | 1 | 1 |
| DTD | Pacemaker Lead Adaptor | 1 | 1 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 1 | 1 |
| DYF | Prosthesis, Vascular Graft, Of Less Then 6mm Diameter | 1 | 1 |
| QEW | Peripheral Mechanical Thrombectomy With Aspiration | 1 | 1 |
Plus 1 more product codes.
Review panels
- Cardiovascular (34)
Most recent Possis Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K133629 | ANGIOJET ULTRA AVX THROMBECTOMY SET | QEW | 2014-02-14 | 80 |
| K091593 | ANGIO JET ULTRA DVX AND XPEEDIOR THROMBECTOMY SETS | QEZ | 2009-06-22 | 20 |
| K090253 | ANGIOJET ULTRA DVX THROMBECTOMY SET, MODEL 106552-001, ANGIOJET ULTRA XPEEDIOR THROMBECTOMY SET, MODEL 105040-001 | QEZ | 2009-04-08 | 65 |
| K082382 | ANGIOJET ULTRA AVX THROMBECTOMY SET, MODEL 105039 | QEZ | 2008-12-12 | 115 |
| K081989 | MODIFICATION TO FETCH ASPIRATION CATHETER | QEZ | 2008-09-26 | 74 |
| K081454 | GUARDDOG OCCLUSION GUIDEWIRE, INFLATION DEVICE | MJN | 2008-06-13 | 21 |
| K080806 | ANGIOJET ULTRA SPIROFLEX VG THROMBECTOMY SET, MODEL 106608 | QEZ | 2008-04-04 | 14 |
| K073441 | ANGIOJET ULTRA AVX THROMBECTOMY SET, MODEL 105039 | QEZ | 2008-01-24 | 48 |
| K072769 | ANGIOJET ULTRA; XMI (105041), XVG (105042) AND SPIROFLEX (106553) THROMBECTOMY SETS | QEZ | 2007-11-14 | 47 |
| K072269 | ANGIOJET ULTRA DVX THROMBECTOMY SET, MODEL: 106552 | QEZ | 2007-09-08 | 24 |
24 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P980017 | PMA | PERMA-SEAL DIALYSIS ACCESS GRAFT MODEL 2C20 | 1998-09-25 |
Recalls
4 product recalls in 3 recall events; 0 initiated in the last five years. Most recent: 2007-06-19.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Possis Medical, Inc. have?
Possis Medical, Inc. has 34 FDA 510(k) clearances (first 1983, latest 2014), plus 1 PMA decision, across 10 product codes in 1 review panel.
How long does FDA take to clear Possis Medical, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Possis Medical, Inc.'s cleared 510(k)s is 72 days.
What devices does Possis Medical, Inc. make?
Its most frequent FDA product codes are QEZ (Aspiration Thrombectomy Catheter, 19); DTB (Permanent Pacemaker Electrode, 5); MJN (Catheter, Intravascular Occluding, Temporary, 3).
Has Possis Medical, Inc. had device recalls?
openFDA lists 4 product recalls in 3 recall events by a recalling firm whose name matches Possis Medical, Inc; the most recent began 2007-06-19. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 34 Possis Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code QEZ, Possis Medical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.