Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic Catheters
FDA 510(k) K231015 · Innovative Health, LLC
510(k) numberK231015
Submission
- Device name
- Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic Catheters
- Applicant
- Innovative Health, LLC
Scottsdale, AZ, US - Received
- April 10, 2023
- Decision date
- July 1, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NLI – Catheter, Angiography, Reprocessed
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1200
- Specialty
- Cardiovascular
Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
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Questions and answers
When was Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic Catheters cleared by the FDA?
Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic Catheters (K231015) received a 510(k) decision of Substantially Equivalent on July 1, 2024, 448 days after the submission was received.
What is the product code of K231015?
The FDA product code is NLI – Catheter, Angiography, Reprocessed, a Class II (moderate risk) device regulated under 21 CFR 870.1200.