The following data is part of a premarket notification filed by Aries Medical, Inc. with the FDA for Aries Taperseal(tm) Sheath.
| Device ID | K903442 |
| 510k Number | K903442 |
| Device Name: | ARIES TAPERSEAL(TM) SHEATH |
| Classification | Introducer, Catheter |
| Applicant | ARIES MEDICAL, INC. 12 ELIZABETH DR. Chelmsford, MA 01824 |
| Contact | James Mayo |
| Correspondent | James Mayo ARIES MEDICAL, INC. 12 ELIZABETH DR. Chelmsford, MA 01824 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-31 |
| Decision Date | 1990-08-23 |