Bridgepoint Medical: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Bridgepoint Medical” (first 2008, latest 2012), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 58 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 6 | 30 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 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 |
|---|---|---|---|
| DQY | Catheter, Percutaneous | 7 | 7 |
| DQX | Wire, Guide, Catheter | 6 | 6 |
| PDU | Catheter For Crossing Total Occlusions | 1 | 1 |
Review panels
- Cardiovascular (14)
Most recent Bridgepoint Medical 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K122795 | STINGRAY GUIDEWIRES | DQX | 2012-11-08 | 57 |
| K121745 | MANTARAY GUIDEWIRES | DQX | 2012-07-13 | 29 |
| K120533 | BIGBOSS CATHETERS MANTATAY CATHETER MANTARAY GUIDEWIRES | PDU | 2012-05-22 | 90 |
| K120881 | MANTARAY GUIDEWIRES | DQX | 2012-04-18 | 26 |
| K120129 | MANTARAY CATHETER | DQY | 2012-02-03 | 17 |
| K113589 | BIGBOSS CATHETER | DQY | 2012-01-04 | 30 |
| K111963 | BRIDGEPOINT MEDICAL MANTARAY(TM) CATHETER | DQY | 2011-08-10 | 30 |
| K111488 | MANTARAY GUIDEWIRE MODEL M-6000, M-6001, M-6002, M-6003 | DQX | 2011-06-30 | 30 |
| K101591 | STINGRAY ORIENTING BALLOON CATHETER | DQY | 2010-08-06 | 60 |
| K091841 | BRIDGEPOINT MEDICAL CROSSBOSS CATHETER, MODEL M-2000 | DQY | 2009-09-02 | 72 |
4 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2012-06-26.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Bridgepoint Medical is the lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT01246505: Peripheral Facilitated Antegrade Steering Technique in Chronic Total Occlusions (Completed, started 2011-07)
- NCT00886899: Facilitated Antegrade Steering Technique in Chronic Total Occlusions (FAST-CTOs) (Completed, started 2009-03)
Frequently asked questions
How many FDA 510(k) clearances are listed under Bridgepoint Medical?
FDA lists 14 510(k) clearances under the applicant name “Bridgepoint Medical” (first 2008, latest 2012), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Bridgepoint Medical?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bridgepoint Medical is 58 days.
Which FDA product codes appear under Bridgepoint Medical?
The most frequent FDA product codes under this applicant name are DQY (Catheter, Percutaneous, 7); DQX (Wire, Guide, Catheter, 6); PDU (Catheter For Crossing Total Occlusions, 1).
Next steps
- See all 14 Bridgepoint Medical clearances with predicates and recalls
- Run predicate analysis for product code DQY, Bridgepoint Medical's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.