091 Balloon Guide Catheter
FDA 510(k) K220331 · Inneuroco, Inc.
510(k) numberK220331
Submission
- Device name
- 091 Balloon Guide Catheter
- Applicant
- Inneuroco, Inc.
Pembroke Pines, FL, US - Received
- February 4, 2022
- Decision date
- July 29, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQY – Catheter, Percutaneous
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
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Questions and answers
When was 091 Balloon Guide Catheter cleared by the FDA?
091 Balloon Guide Catheter (K220331) received a 510(k) decision of Substantially Equivalent on July 29, 2022, 175 days after the submission was received.
What is the product code of K220331?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.