The following data is part of a premarket notification filed by Thomas Medical Products, Inc. with the FDA for Guide Catheters And Accessories.
| Device ID | K101015 |
| 510k Number | K101015 |
| Device Name: | GUIDE CATHETERS AND ACCESSORIES |
| Classification | Catheter, Percutaneous |
| Applicant | THOMAS MEDICAL PRODUCTS, INC. 65 GREAT VALLEY PKWY. Malvern, PA 19355 |
| Contact | Tim Stoudt |
| Correspondent | Tim Stoudt THOMAS MEDICAL PRODUCTS, INC. 65 GREAT VALLEY PKWY. Malvern, PA 19355 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-12 |
| Decision Date | 2010-09-23 |
| Summary: | summary |