The following data is part of a premarket notification filed by Thomas Medical Products, Inc. with the FDA for Transseptal Introducer Set.
| Device ID | K932619 |
| 510k Number | K932619 |
| Device Name: | TRANSSEPTAL INTRODUCER SET |
| Classification | Catheter, Percutaneous |
| Applicant | THOMAS MEDICAL PRODUCTS, INC. 65 GREAT VALLEY PKWY. Malvern, PA 19355 |
| Contact | David G Catlin |
| Correspondent | David G Catlin 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 | 1993-06-01 |
| Decision Date | 1993-08-24 |