MEDI-TECH SELECTIVE TORQUE CATHETER
FDA 510(k) clearance K864118 · decided 1987-04-09
Clearance details
- K-number
- K864118
- Device name
- MEDI-TECH SELECTIVE TORQUE CATHETER
- Applicant
- Medi-Tech, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-10-21
- Decision date
- 1987-04-09
- Days to decision
- 170 days
- Clearance type
- Traditional
- Product code
- DQY
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Watertown, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.