The following data is part of a premarket notification filed by Datascope Corp. with the FDA for Datascope Percor Percutaneous Introducer W/peelabl.
| Device ID | K902932 |
| 510k Number | K902932 |
| Device Name: | DATASCOPE PERCOR PERCUTANEOUS INTRODUCER W/PEELABL |
| Classification | Introducer, Catheter |
| Applicant | DATASCOPE CORP. 3 FIR CT. P.O. BOX 3100 Oakland, NJ 07436 |
| Contact | Bill Corrigan |
| Correspondent | Bill Corrigan DATASCOPE CORP. 3 FIR CT. P.O. BOX 3100 Oakland, NJ 07436 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-03 |
| Decision Date | 1990-10-16 |