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FDA 510(k)

ASAP Aspiration Catheter, ASAPLP Aspiration Catheter

K-Number: K212199 · 2021-11-03

ApplicantMerit Medical Systems, Inc.
Decision Date2021-11-03
Product CodeQEZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ASAP Aspiration Catheter, ASAPLP Aspiration Catheter is a medical device manufactured by Merit Medical Systems, Inc.. It received FDA 510(k) clearance on 2021-11-03 under approval number K212199. The device is classified under product code QEZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASAP Aspiration Catheter, ASAPLP Aspiration Catheter?

ASAP Aspiration Catheter, ASAPLP Aspiration Catheter is a medical device that received FDA 510(k) clearance on 2021-11-03. It is manufactured by Merit Medical Systems, Inc.. The 510(k) number is K212199.

When was ASAP Aspiration Catheter, ASAPLP Aspiration Catheter approved by the FDA?

ASAP Aspiration Catheter, ASAPLP Aspiration Catheter received FDA 510(k) clearance on 2021-11-03, under approval number K212199.

What company makes ASAP Aspiration Catheter, ASAPLP Aspiration Catheter?

ASAP Aspiration Catheter, ASAPLP Aspiration Catheter is manufactured by Merit Medical Systems, Inc..

What is the FDA product code for ASAP Aspiration Catheter, ASAPLP Aspiration Catheter?

The FDA product code for ASAP Aspiration Catheter, ASAPLP Aspiration Catheter is QEZ.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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