The following data is part of a premarket notification filed by Aries Medical, Inc. with the FDA for Aries Peel Away Percutaneous Catheter Introducer.
| Device ID | K871140 |
| 510k Number | K871140 |
| Device Name: | ARIES PEEL AWAY PERCUTANEOUS CATHETER INTRODUCER |
| Classification | Introducer, Catheter |
| Applicant | ARIES MEDICAL, INC. 45 WEST ST. SUITE 2 Attleboro, MA 02703 |
| Contact | James R Veale |
| Correspondent | James R Veale ARIES MEDICAL, INC. 45 WEST ST. SUITE 2 Attleboro, MA 02703 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-23 |
| Decision Date | 1987-04-22 |