FDA 510(k)

Slinky Catheter

K-Number: K231179 · 2023-12-01

Decision Date2023-12-01

Product CodeQJP

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Slinky Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Anoxia Medical, Inc.. It received FDA 510(k) clearance on 2023-12-01 under 510(k) number K231179. The device is classified under product code QJP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Slinky Catheter?

Slinky Catheter is a medical device that received FDA 510(k) clearance on 2023-12-01. The listed applicant is Anoxia Medical, Inc.. The 510(k) number is K231179.

When did Slinky Catheter receive FDA 510(k) clearance?

Slinky Catheter received FDA 510(k) clearance on 2023-12-01, under 510(k) number K231179.

Who is the listed applicant for Slinky Catheter?

The FDA 510(k) record lists Anoxia Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Slinky Catheter?

The FDA product code for Slinky Catheter is QJP.

Other records listing Anoxia Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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