TORONTO RF SEPTOSTOMY CATHETER, MODEL TSC-50-75
FDA 510(k) clearance K031949 · decided 2003-12-10
Clearance details
- K-number
- K031949
- Device name
- TORONTO RF SEPTOSTOMY CATHETER, MODEL TSC-50-75
- Applicant
- Baylis Medical Co., Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-06-24
- Decision date
- 2003-12-10
- Days to decision
- 169 days
- Clearance type
- Traditional
- Product code
- DXF
- Device class
- 2
- Regulation number
- 870.5175
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mississauga, Ontario, CA
- Third-party review
- No
- Expedited review
- No
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| HOTWIRE™ RF Guidewire (K240900) | Atraverse Medical | 2024-05-01 |
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Recalls involving this device
No recalls on record reference this clearance.