Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic Catheters
FDA 510(k) clearance K231015 · decided 2024-07-01
Clearance details
- K-number
- K231015
- Device name
- Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic Catheters
- Applicant
- Innovative Health, LLC
- Decision
- Substantially Equivalent
- Date received
- 2023-04-10
- Decision date
- 2024-07-01
- Days to decision
- 448 days
- Clearance type
- Traditional
- Product code
- NLI
- Device class
- 2
- Regulation number
- 870.1200
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Scottsdale, AZ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.