The following data is part of a premarket notification filed by Baylis Medical Co., Inc. with the FDA for Powerwire Radiofrequency Guidewire.
| Device ID | K101615 |
| 510k Number | K101615 |
| Device Name: | POWERWIRE RADIOFREQUENCY GUIDEWIRE |
| Classification | Catheter For Crossing Total Occlusions |
| Applicant | BAYLIS MEDICAL CO., INC. 2645 MATHESON BLVD. E Mississauga, Ontario, CA L4w 5s4 |
| Contact | Meghal Khakhar |
| Correspondent | Meghal Khakhar BAYLIS MEDICAL CO., INC. 2645 MATHESON BLVD. E Mississauga, Ontario, CA L4w 5s4 |
| Product Code | PDU |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-09 |
| Decision Date | 2010-07-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00685447001089 | K101615 | 000 |
| 07540299000235 | K101615 | 000 |
| 07540299000242 | K101615 | 000 |
| 07540299000259 | K101615 | 000 |
| 07540299000266 | K101615 | 000 |
| 07540299000273 | K101615 | 000 |
| 00685447001034 | K101615 | 000 |
| 00685447001041 | K101615 | 000 |
| 00685447001058 | K101615 | 000 |
| 00685447001065 | K101615 | 000 |
| 00685447001072 | K101615 | 000 |
| 07540299000228 | K101615 | 000 |