FDA 510(k)

COEUR 130 ML ANGIOGRAPHIC SYRINGE

K-Number: K971712 · 1997-10-08

Decision Date1997-10-08

Product CodeDXT

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

COEUR 130 ML ANGIOGRAPHIC SYRINGE is the device name listed in this FDA 510(k) record. The listed applicant is Coeur Laboratories, Inc.. It received FDA 510(k) clearance on 1997-10-08 under 510(k) number K971712. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COEUR 130 ML ANGIOGRAPHIC SYRINGE?

COEUR 130 ML ANGIOGRAPHIC SYRINGE is a medical device that received FDA 510(k) clearance on 1997-10-08. The listed applicant is Coeur Laboratories, Inc.. The 510(k) number is K971712.

When did COEUR 130 ML ANGIOGRAPHIC SYRINGE receive FDA 510(k) clearance?

COEUR 130 ML ANGIOGRAPHIC SYRINGE received FDA 510(k) clearance on 1997-10-08, under 510(k) number K971712.

Who is the listed applicant for COEUR 130 ML ANGIOGRAPHIC SYRINGE?

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

What is the FDA product code for COEUR 130 ML ANGIOGRAPHIC SYRINGE?

The FDA product code for COEUR 130 ML ANGIOGRAPHIC SYRINGE is DXT.

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Other records listing Coeur Laboratories, Inc. as applicant

K965214COEUR FRONT LOAD INJECTOR RETROFIT KIT (C859-0002)K960965FRONT LOAD INJECTOR TURRET MODEL 859-0001/200 ML FRONT LOAD SYRINGE MODEL 853-0211 K890292PCA-10, 10CC DISP. ANGIOGRAPHY CONTROL SYRINGE K885138CAPILLARY TUBE, BLOOD COLLECTION K88520216 LONG CATHETER W/ADAPTER, 14 FR AND 12 FR K881646UROLOGICAL CATHETER

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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.