Usci, Div. C.R. Bard, Inc.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Usci, Div. C.R. Bard, Inc.” (first 1976, latest 1995), plus 1 PMA decision, across 9 product codes in 1 review panel. Median 510(k) review time under this name: 26 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 | 0 | — |
| 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 |
|---|---|---|---|
| DSY | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter | 3 | 3 |
| DYB | Introducer, Catheter | 3 | 3 |
| DQX | Wire, Guide, Catheter | 1 | 1 |
| DQY | Catheter, Percutaneous | 1 | 1 |
| DRE | Dilator, Vessel, For Percutaneous Catheterization | 1 | 1 |
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | 1 | 1 |
| DXZ | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | 1 | 1 |
| DYG | Catheter, Flow Directed | 1 | 1 |
| LOX | Catheters, Transluminal Coronary Angioplasty, Percutaneous | 1 | 0 |
Review panels
- Cardiovascular (13)
Most recent Usci, Div. C.R. Bard, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K940092 | USCI INPUT INTRODUCER SET | DYB | 1995-08-10 | 580 |
| K884209 | USCI DORROS INFUSION/PROBING CATHETER | DQY | 1988-12-21 | 76 |
| K771823 | CATHETER, CARDIOVASCULAR | DYG | 1977-12-20 | 88 |
| K772021 | TRC STAINLESS STEEL SAFETY SPRING GUIDES | DQX | 1977-11-02 | 7 |
| K771982 | 888 ARTERIAL/VENOUS CATHETER INTRODUCER | DYB | 1977-11-02 | 15 |
| K770835 | PATCH FABRIC | DXZ | 1977-10-05 | 152 |
| K770561 | CATHETER,PERCUTANEOUS INTRODUC. & SHEATH | DYB | 1977-04-26 | 34 |
| K770236 | SAUVAGE FILAMENTOUS PROSTHESES | DSY | 1977-02-25 | 18 |
| K770235 | DEBAKEY VASCULOUR-D PROSTHESES | DSY | 1977-02-24 | 17 |
| K760843 | PALEY TRANSPARENT MANIFOLD | DTL | 1976-11-12 | 29 |
2 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P890048 | PMA | USCI PROBE III BALLOON-ON-A-WIRE DILATATION SYSTEM | 1991-04-17 |
Recalls
openFDA lists no recalls under a recalling firm named Usci, Div. C.R. Bard, Inc..
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Usci, Div. C.R. Bard, Inc. (a text match, not an official crosswalk):
- C9602 — Percutaneous transluminal coronary atherectomy, with drug eluting intracoronary stent, with coronary angioplasty when performed; single major coronary artery or branch (via LOX)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Usci Ireland (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Usci, Div. C.R. Bard, Inc.?
FDA lists 12 510(k) clearances under the applicant name “Usci, Div. C.R. Bard, Inc.” (first 1976, latest 1995), plus 1 PMA decision, across 9 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 Usci, Div. C.R. Bard, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Usci, Div. C.R. Bard, Inc. is 26 days.
Which FDA product codes appear under Usci, Div. C.R. Bard, Inc.?
The most frequent FDA product codes under this applicant name are DSY (Prosthesis, Vascular Graft, Of 6mm And Greater Diameter, 3); DYB (Introducer, Catheter, 3); DQX (Wire, Guide, Catheter, 1).
Next steps
- See all 12 Usci, Div. C.R. Bard, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DSY, Usci, Div. C.R. Bard, Inc.'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.