The following data is part of a premarket notification filed by Aries Medical, Inc. with the FDA for Aries Tapered Sheath.
| Device ID | K870189 |
| 510k Number | K870189 |
| Device Name: | ARIES TAPERED SHEATH |
| Classification | Introducer, Catheter |
| Applicant | ARIES MEDICAL, INC. TWO GILL ST. Woburn, MA 01801 |
| Contact | Michael L Rishton |
| Correspondent | Michael L Rishton ARIES MEDICAL, INC. TWO GILL ST. Woburn, MA 01801 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-01-16 |
| Decision Date | 1987-03-16 |