FDA 510(k)

TRUFILL DCS SYRINGE

K-Number: K082324 · 2008-09-12

Decision Date2008-09-12

Product CodeHCG

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

TRUFILL DCS SYRINGE is the device name listed in this FDA 510(k) record. The listed applicant is Cordis Neurovascular, Inc.. It received FDA 510(k) clearance on 2008-09-12 under 510(k) number K082324. The device is classified under product code HCG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRUFILL DCS SYRINGE?

TRUFILL DCS SYRINGE is a medical device that received FDA 510(k) clearance on 2008-09-12. The listed applicant is Cordis Neurovascular, Inc.. The 510(k) number is K082324.

When did TRUFILL DCS SYRINGE receive FDA 510(k) clearance?

TRUFILL DCS SYRINGE received FDA 510(k) clearance on 2008-09-12, under 510(k) number K082324.

Who is the listed applicant for TRUFILL DCS SYRINGE?

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

What is the FDA product code for TRUFILL DCS SYRINGE?

The FDA product code for TRUFILL DCS SYRINGE is HCG.

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Other records listing Cordis Neurovascular, Inc. as applicant

K080967TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE OR TRUFILL DCS SYRINGE II, ALSO KNOWN AS THE TRUFILL DCS ORBIT K071962VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS AND TRUPUSH COIL PUSHER)K070279MODIFICATION TO HYPERTRANSIT INFUSION CATHETER K063254THE TRUFILL DCS DETACHABLE COIL SYSTEM; THE TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM K053197TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM LINE EXTENSION K043538HYPERTRANSIT INFUSION CATHETER

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Related Devices (Code: HCG)

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.