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FDA 510(k)

SINGLE LUMEN EMBOLECTOMY CATHETER

K-Number: K972572 · 1998-01-13

ApplicantAmerican Biomed, Inc.
Decision Date1998-01-13
Product CodeDXE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SINGLE LUMEN EMBOLECTOMY CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is American Biomed, Inc.. It received FDA 510(k) clearance on 1998-01-13 under 510(k) number K972572. The device is classified under product code DXE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SINGLE LUMEN EMBOLECTOMY CATHETER?

SINGLE LUMEN EMBOLECTOMY CATHETER is a medical device that received FDA 510(k) clearance on 1998-01-13. The listed applicant is American Biomed, Inc.. The 510(k) number is K972572.

When did SINGLE LUMEN EMBOLECTOMY CATHETER receive FDA 510(k) clearance?

SINGLE LUMEN EMBOLECTOMY CATHETER received FDA 510(k) clearance on 1998-01-13, under 510(k) number K972572.

Who is the listed applicant for SINGLE LUMEN EMBOLECTOMY CATHETER?

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

What is the FDA product code for SINGLE LUMEN EMBOLECTOMY CATHETER?

The FDA product code for SINGLE LUMEN EMBOLECTOMY CATHETER is DXE.

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Related Devices (Code: DXE)

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.

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