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FDA 510(k)

091 Balloon Guide Catheter

K-Number: K220331 · 2022-07-29

ApplicantInneuroco, Inc.
Decision Date2022-07-29
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

091 Balloon Guide Catheter is a medical device manufactured by Inneuroco, Inc.. It received FDA 510(k) clearance on 2022-07-29 under approval number K220331. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 091 Balloon Guide Catheter?

091 Balloon Guide Catheter is a medical device that received FDA 510(k) clearance on 2022-07-29. It is manufactured by Inneuroco, Inc.. The 510(k) number is K220331.

When was 091 Balloon Guide Catheter approved by the FDA?

091 Balloon Guide Catheter received FDA 510(k) clearance on 2022-07-29, under approval number K220331.

What company makes 091 Balloon Guide Catheter?

091 Balloon Guide Catheter is manufactured by Inneuroco, Inc..

What is the FDA product code for 091 Balloon Guide Catheter?

The FDA product code for 091 Balloon Guide Catheter is DQY.

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Other Devices by Inneuroco, Inc.

K161262Super Distal Access (SDA) K172468091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cm K171672065 Zenith, 074 Zenith K181354074 Zenith Flex System K172167Zenith Flex System K173709Zenith Support, 95 cm, Zenith Support, 105 cm, Zenith Support, 115 cm

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Related Devices (Code: DQY)

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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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