510(k) K231015
- Device
- Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic Catheters
- Applicant
- Innovative Health, LLC
- 510(k) number
- K231015
- Product code
- NLI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-07-01
- Date received
- 2023-04-10
- Regulation
- 870.1200
- Classification name
- Catheter, Angiography, Reprocessed
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Rick Ferreira
- Address
- 1435 N. Hayden Rd. Suite 100 Scottsdale AZ US 85257 85257