The following data is part of a premarket notification filed by Ep Medsystems with the FDA for Procath Locking Peel-away Introducer/peel-away Introducer Set.
| Device ID | K961513 |
| 510k Number | K961513 |
| Device Name: | PROCATH LOCKING PEEL-AWAY INTRODUCER/PEEL-AWAY INTRODUCER SET |
| Classification | Introducer, Catheter |
| Applicant | EP MEDSYSTEMS 334 D-6 COOPER RD. Berlin, NJ 08009 |
| Contact | Joseph C Griffin |
| Correspondent | Joseph C Griffin EP MEDSYSTEMS 334 D-6 COOPER RD. Berlin, NJ 08009 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-19 |
| Decision Date | 1996-05-13 |