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FDA 510(k)

EXPANDED USE OF HARDSHELL VENOUS RESERV. W/FILTER

K-Number: K872719 · 1987-09-30

ApplicantShiley, Inc.
Decision Date1987-09-30
Product CodeDTN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EXPANDED USE OF HARDSHELL VENOUS RESERV. W/FILTER is the device name listed in this FDA 510(k) record. The listed applicant is Shiley, Inc.. It received FDA 510(k) clearance on 1987-09-30 under 510(k) number K872719. The device is classified under product code DTN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXPANDED USE OF HARDSHELL VENOUS RESERV. W/FILTER?

EXPANDED USE OF HARDSHELL VENOUS RESERV. W/FILTER is a medical device that received FDA 510(k) clearance on 1987-09-30. The listed applicant is Shiley, Inc.. The 510(k) number is K872719.

When did EXPANDED USE OF HARDSHELL VENOUS RESERV. W/FILTER receive FDA 510(k) clearance?

EXPANDED USE OF HARDSHELL VENOUS RESERV. W/FILTER received FDA 510(k) clearance on 1987-09-30, under 510(k) number K872719.

Who is the listed applicant for EXPANDED USE OF HARDSHELL VENOUS RESERV. W/FILTER?

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 EXPANDED USE OF HARDSHELL VENOUS RESERV. W/FILTER?

The FDA product code for EXPANDED USE OF HARDSHELL VENOUS RESERV. W/FILTER is DTN.

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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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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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