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FDA 510(k)

CATHETER, ARTERIAL EMBOLECTOMY

K-Number: K770714 · 1977-04-27

ApplicantMallinckrodt Critical Care
Decision Date1977-04-27
Product CodeDXE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CATHETER, ARTERIAL EMBOLECTOMY is the device name listed in this FDA 510(k) record. The listed applicant is Mallinckrodt Critical Care. It received FDA 510(k) clearance on 1977-04-27 under 510(k) number K770714. 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 CATHETER, ARTERIAL EMBOLECTOMY?

CATHETER, ARTERIAL EMBOLECTOMY is a medical device that received FDA 510(k) clearance on 1977-04-27. The listed applicant is Mallinckrodt Critical Care. The 510(k) number is K770714.

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

CATHETER, ARTERIAL EMBOLECTOMY received FDA 510(k) clearance on 1977-04-27, under 510(k) number K770714.

Who is the listed applicant for CATHETER, ARTERIAL EMBOLECTOMY?

The FDA 510(k) record lists Mallinckrodt Critical Care as the applicant. This does not by itself establish the device manufacturer.

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

The FDA product code for CATHETER, ARTERIAL EMBOLECTOMY is DXE.

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Other records listing Mallinckrodt Critical Care as applicant

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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

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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