The following data is part of a premarket notification filed by Baylis Medical Co., Inc. with the FDA for Rf Tunneler Wire.
| Device ID | K051670 |
| 510k Number | K051670 |
| Device Name: | RF TUNNELER WIRE |
| Classification | Catheter For Crossing Total Occlusions |
| Applicant | BAYLIS MEDICAL CO., INC. 2580 MATHESON BLVD. E Mississauga, Ontario, CA L4w 4j1 |
| Contact | Meghal Khakhar |
| Correspondent | Meghal Khakhar BAYLIS MEDICAL CO., INC. 2580 MATHESON BLVD. E Mississauga, Ontario, CA L4w 4j1 |
| Product Code | PDU |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-22 |
| Decision Date | 2006-03-30 |
| Summary: | summary |