The following data is part of a premarket notification filed by Medical Device Technologies, Inc. with the FDA for En-snare Endovascular Snare And Catheter.
| Device ID | K021606 |
| 510k Number | K021606 |
| Device Name: | EN-SNARE ENDOVASCULAR SNARE AND CATHETER |
| Classification | Device, Percutaneous Retrieval |
| Applicant | MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW 47TH AVENUE Gainesville, FL 32608 |
| Contact | Karl Swartz |
| Correspondent | N.e. Devine ENTELA, INC. 3033 MADISON AVENUE, SE Grand Rapids, MI 49548 |
| Product Code | MMX |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2002-05-16 |
| Decision Date | 2002-05-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20886333004021 | K021606 | 000 |
| 20886333004014 | K021606 | 000 |
| 20886333004007 | K021606 | 000 |
| 20886333003994 | K021606 | 000 |
| 20886333003987 | K021606 | 000 |
| 20886333003970 | K021606 | 000 |
| 20886333003963 | K021606 | 000 |