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FDA 510(k)

EMBOLECTOMY CATHETER, EXTEND. SHELF LIFE

K-Number: K780762 · 1978-05-26

ApplicantShiley, Inc.
Decision Date1978-05-26
Product CodeDXE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EMBOLECTOMY CATHETER, EXTEND. SHELF LIFE is the device name listed in this FDA 510(k) record. The listed applicant is Shiley, Inc.. It received FDA 510(k) clearance on 1978-05-26 under 510(k) number K780762. 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 EMBOLECTOMY CATHETER, EXTEND. SHELF LIFE?

EMBOLECTOMY CATHETER, EXTEND. SHELF LIFE is a medical device that received FDA 510(k) clearance on 1978-05-26. The listed applicant is Shiley, Inc.. The 510(k) number is K780762.

When did EMBOLECTOMY CATHETER, EXTEND. SHELF LIFE receive FDA 510(k) clearance?

EMBOLECTOMY CATHETER, EXTEND. SHELF LIFE received FDA 510(k) clearance on 1978-05-26, under 510(k) number K780762.

Who is the listed applicant for EMBOLECTOMY CATHETER, EXTEND. SHELF LIFE?

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

What is the FDA product code for EMBOLECTOMY CATHETER, EXTEND. SHELF LIFE?

The FDA product code for EMBOLECTOMY CATHETER, EXTEND. SHELF LIFE is DXE.

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Other records listing Shiley, Inc. as applicant

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K920594SHILEY PERFUSION TUBING SETSK910991SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEMK911876SHILEY PLEXUS(R) VENOUS RESERVOIR, PVR1200K910923BCD ADVANCEDK901548BIOMEDICAL SENSORS-SHILEY BGM 4000 INTRA BLOOD GASK903435SHILEY SPECIALIZED TRACHEOSTOMY TUBE

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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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