The following data is part of a premarket notification filed by Thomas Medical Products, Inc. with the FDA for Reinforced Catheter Introducer System (rcis).
| Device ID | K081341 |
| 510k Number | K081341 |
| Device Name: | REINFORCED CATHETER INTRODUCER SYSTEM (RCIS) |
| Classification | Introducer, Catheter |
| Applicant | THOMAS MEDICAL PRODUCTS, INC. 65 GREAT VALLEY PKWY. Malvern, PA 19355 |
| Contact | Tim Stoudt |
| Correspondent | Jay Y Kogoma INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-05-13 |
| Decision Date | 2008-05-14 |
| Summary: | summary |