510(k) K002365 ยท DYB Introducer, Catheter
DATASCOPE REINFORCED PERCUTANEOUS CATHETER INTRODUCER SET
| Applicant | Datascope Corp., Fairfield NJ, US |
| Decision | Substantially Equivalent, Aug 25, 2000 |
| Received | Aug 3, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K002365
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 21, 2023 | Datascope Corp. REINFORCED INTRODUCER SET, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta
Product Description Open, Classified |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.