FDA 510(k)

CATHETERS, ARTERIAL EMBOLECTOMY

K-Number: K780244 · 1978-04-13

ApplicantExtracorporeal Medical Specialities, Inc.

Decision Date1978-04-13

Product CodeDXE

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

CATHETERS, ARTERIAL EMBOLECTOMY is the device name listed in this FDA 510(k) record. The listed applicant is Extracorporeal Medical Specialities, Inc.. It received FDA 510(k) clearance on 1978-04-13 under 510(k) number K780244. 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 CATHETERS, ARTERIAL EMBOLECTOMY?

CATHETERS, ARTERIAL EMBOLECTOMY is a medical device that received FDA 510(k) clearance on 1978-04-13. The listed applicant is Extracorporeal Medical Specialities, Inc.. The 510(k) number is K780244.

When did CATHETERS, ARTERIAL EMBOLECTOMY receive FDA 510(k) clearance?

CATHETERS, ARTERIAL EMBOLECTOMY received FDA 510(k) clearance on 1978-04-13, under 510(k) number K780244.

Who is the listed applicant for CATHETERS, ARTERIAL EMBOLECTOMY?

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

What is the FDA product code for CATHETERS, ARTERIAL EMBOLECTOMY?

The FDA product code for CATHETERS, ARTERIAL EMBOLECTOMY is 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.