TORFLEX TRANSSEPTAL GUIDING SHEATH
FDA 510(k) clearance K102948 · decided 2011-04-01
Clearance details
- K-number
- K102948
- Device name
- TORFLEX TRANSSEPTAL GUIDING SHEATH
- Applicant
- Baylis Medical Co., Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-10-05
- Decision date
- 2011-04-01
- Days to decision
- 178 days
- Clearance type
- Traditional
- Product code
- DYB
- Device class
- 2
- Regulation number
- 870.1340
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mississauga, Ontario, CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| TorFlex Transseptal Guiding Sheath ; Model numbers: TF8-32-63-45, TF8-32-63-55, TF8-32-63- recall (Z-2069-2020) | Baylis Medical Company Inc. | 2020-05-21 |
| NRG RF Transseptal Kit; Model No.s : NTK-710-8545, NTK-710-8555, NTK-711-8545, NTK-711-855 recall (Z-2070-2020) | Baylis Medical Company Inc. | 2020-05-21 |
| Baylis Medical TorFlex Transseptal Guiding Sheath, Rx Only, non-pyrogenic, sterile. Produc recall (Z-0085-2014) | Baylis Medical Corp * | 2013-11-01 |