The following data is part of a premarket notification filed by Datascope Corp. with the FDA for Datascope Reinforced Percutaneous Catheter Introducer Set.
| Device ID | K002365 |
| 510k Number | K002365 |
| Device Name: | DATASCOPE REINFORCED PERCUTANEOUS CATHETER INTRODUCER SET |
| Classification | Introducer, Catheter |
| Applicant | DATASCOPE CORP. 15 LAW DR. Fairfield, NJ 07004 -3206 |
| Contact | Joann Wolf |
| Correspondent | Joann Wolf DATASCOPE CORP. 15 LAW DR. Fairfield, NJ 07004 -3206 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-03 |
| Decision Date | 2000-08-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10607567107943 | K002365 | 000 |
| 10607567106694 | K002365 | 000 |
| 10607567106656 | K002365 | 000 |