The following data is part of a premarket notification filed by Thomas Medical Products, Inc. with the FDA for Transseptal Needle/trocar.
| Device ID | K011727 |
| 510k Number | K011727 |
| Device Name: | TRANSSEPTAL NEEDLE/TROCAR |
| Classification | Trocar |
| 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 | DRC |
| CFR Regulation Number | 870.1390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-04 |
| Decision Date | 2002-05-02 |
| Summary: | summary |