The following data is part of a premarket notification filed by Medical Device Technologies, Inc. with the FDA for Pbn Guidewires.
| Device ID | K031442 |
| 510k Number | K031442 |
| Device Name: | PBN GUIDEWIRES |
| Classification | Wire, Guide, Catheter |
| Applicant | MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW 47TH AVENUE Gainesville, FL 32608 |
| Contact | Karl Swartz |
| Correspondent | Karl Swartz MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW 47TH AVENUE Gainesville, FL 32608 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-06 |
| Decision Date | 2003-08-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20886333000757 | K031442 | 000 |
| 20886333000740 | K031442 | 000 |
| 20886333000733 | K031442 | 000 |