The following data is part of a premarket notification filed by Portlyn Corp. with the FDA for Dynabite Cardiovascular Biopsy Forceps.
| Device ID | K951447 |
| 510k Number | K951447 |
| Device Name: | DYNABITE CARDIOVASCULAR BIOPSY FORCEPS |
| Classification | Device, Biopsy, Endomyocardial |
| Applicant | PORTLYN CORP. RFD 1, BOX 451 ROUTE 25 Moultonboro, NH 03254 |
| Contact | George A Lyna |
| Correspondent | George A Lyna PORTLYN CORP. RFD 1, BOX 451 ROUTE 25 Moultonboro, NH 03254 |
| Product Code | DWZ |
| CFR Regulation Number | 870.4075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-29 |
| Decision Date | 1995-07-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20886333206869 | K951447 | 000 |
| 20886333206715 | K951447 | 000 |
| 20886333206722 | K951447 | 000 |
| 20886333206739 | K951447 | 000 |
| 20886333206746 | K951447 | 000 |
| 20886333206753 | K951447 | 000 |
| 20886333206777 | K951447 | 000 |
| 20886333206784 | K951447 | 000 |
| 20886333206791 | K951447 | 000 |
| 20886333206807 | K951447 | 000 |
| 20886333206814 | K951447 | 000 |
| 20886333206821 | K951447 | 000 |
| 20886333206838 | K951447 | 000 |
| 20886333206845 | K951447 | 000 |
| 20886333206852 | K951447 | 000 |
| 20886333206708 | K951447 | 000 |