The following data is part of a premarket notification filed by Baylis Medical Co., Inc. with the FDA for Torflex Transseptal Guiding Sheath.
| Device ID | K102948 |
| 510k Number | K102948 |
| Device Name: | TORFLEX TRANSSEPTAL GUIDING SHEATH |
| Classification | Introducer, Catheter |
| 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 | DYB |
| Subsequent Product Code | DQY |
| Subsequent Product Code | DRE |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-05 |
| Decision Date | 2011-04-01 |
| Summary: | summary |