The following data is part of a premarket notification filed by Baylis Medical Co., Inc. with the FDA for Lev-or Dilation Catheter Otw.
| Device ID | K101117 |
| 510k Number | K101117 |
| Device Name: | LEV-OR DILATION CATHETER OTW |
| Classification | Catheter, Percutaneous |
| 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 | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-21 |
| Decision Date | 2010-07-16 |
| Summary: | summary |