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FDA 510(k)

DUAL LUMEN EMBOLECTOMY CATHETER

K-Number: K970762 · 1997-03-28

ApplicantApplied Medical Resources
Decision Date1997-03-28
Product CodeDXE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DUAL LUMEN EMBOLECTOMY CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical Resources. It received FDA 510(k) clearance on 1997-03-28 under 510(k) number K970762. 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 DUAL LUMEN EMBOLECTOMY CATHETER?

DUAL LUMEN EMBOLECTOMY CATHETER is a medical device that received FDA 510(k) clearance on 1997-03-28. The listed applicant is Applied Medical Resources. The 510(k) number is K970762.

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

DUAL LUMEN EMBOLECTOMY CATHETER received FDA 510(k) clearance on 1997-03-28, under 510(k) number K970762.

Who is the listed applicant for DUAL LUMEN EMBOLECTOMY CATHETER?

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

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

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

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Related Devices (Code: DXE)

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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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