The following data is part of a premarket notification filed by Baylis Medical Co., Inc. with the FDA for Sureflex Steerable Guiding Sheath Kit.
| Device ID | K122926 |
| 510k Number | K122926 |
| Device Name: | SUREFLEX STEERABLE GUIDING SHEATH KIT |
| 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 |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-24 |
| Decision Date | 2013-01-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00685447002574 | K122926 | 000 |
| 00685447000839 | K122926 | 000 |
| 00685447004622 | K122926 | 000 |
| 00685447004615 | K122926 | 000 |
| 00685447004608 | K122926 | 000 |
| 00685447005667 | K122926 | 000 |
| 00685447005650 | K122926 | 000 |
| 00685447005643 | K122926 | 000 |
| 00685447005629 | K122926 | 000 |
| 00685447005612 | K122926 | 000 |
| 00685447000846 | K122926 | 000 |
| 00685447000853 | K122926 | 000 |
| 00685447002567 | K122926 | 000 |
| 00685447002550 | K122926 | 000 |
| 00685447001706 | K122926 | 000 |
| 00685447001690 | K122926 | 000 |
| 00685447001683 | K122926 | 000 |
| 00685447001676 | K122926 | 000 |
| 00685447001669 | K122926 | 000 |
| 00685447001270 | K122926 | 000 |
| 00685447000860 | K122926 | 000 |
| 00685447005605 | K122926 | 000 |