The following data is part of a premarket notification filed by Thomas Medical Products, Inc. with the FDA for Large Bore Splittable Introducer Kit.
| Device ID | K043438 |
| 510k Number | K043438 |
| Device Name: | LARGE BORE SPLITTABLE INTRODUCER KIT |
| Classification | Introducer, Catheter |
| 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 | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-14 |
| Decision Date | 2005-02-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884450258191 | K043438 | 000 |