The following data is part of a premarket notification filed by Microvena Corp. with the FDA for Amplatz Goose Neck Snare Kit/ Catheter.
| Device ID | K972511 |
| 510k Number | K972511 |
| Device Name: | AMPLATZ GOOSE NECK SNARE KIT/ CATHETER |
| Classification | Catheter, Embolectomy |
| Applicant | MICROVENA CORP. 1861 BUERKLE RD. White Bear Lake, MN 55110 -5426 |
| Contact | Janell Colley |
| Correspondent | Janell Colley MICROVENA CORP. 1861 BUERKLE RD. White Bear Lake, MN 55110 -5426 |
| Product Code | DXE |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-03 |
| Decision Date | 1998-03-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821684005064 | K972511 | 000 |
| 00763000225360 | K972511 | 000 |
| 00763000225353 | K972511 | 000 |
| 00763000225346 | K972511 | 000 |
| 00763000225339 | K972511 | 000 |
| 00763000225322 | K972511 | 000 |
| 00763000225315 | K972511 | 000 |
| 00763000225308 | K972511 | 000 |
| 00763000225292 | K972511 | 000 |
| 00763000225285 | K972511 | 000 |
| 00763000225278 | K972511 | 000 |
| 00763000225261 | K972511 | 000 |
| 00763000225254 | K972511 | 000 |
| 00821684004012 | K972511 | 000 |
| 00821684004029 | K972511 | 000 |
| 00821684005033 | K972511 | 000 |
| 00821684004180 | K972511 | 000 |
| 00821684004173 | K972511 | 000 |
| 00821684004166 | K972511 | 000 |
| 00821684004159 | K972511 | 000 |
| 00821684004128 | K972511 | 000 |
| 00821684004111 | K972511 | 000 |
| 00821684004074 | K972511 | 000 |
| 00821684004067 | K972511 | 000 |
| 00821684004050 | K972511 | 000 |
| 00821684004043 | K972511 | 000 |
| 00821684004036 | K972511 | 000 |
| 00763000225247 | K972511 | 000 |