The following data is part of a premarket notification filed by Tran Pa-c, Inc. with the FDA for Trans-catheter Extractor.
| Device ID | K063048 |
| 510k Number | K063048 |
| Device Name: | TRANS-CATHETER EXTRACTOR |
| Classification | Tunneled Catheter Remover |
| Applicant | TRAN PA-C, INC. 3348 HERRINGRIDGE DR. Orlando, FL 32812 |
| Contact | Tom Tran |
| Correspondent | Tom Tran TRAN PA-C, INC. 3348 HERRINGRIDGE DR. Orlando, FL 32812 |
| Product Code | ODY |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-04 |
| Decision Date | 2007-09-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884450052584 | K063048 | 000 |
| 10884450051334 | K063048 | 000 |
| 10884450045494 | K063048 | 000 |