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FDA 510(k)

ATRIUM MEDICAL CORPORATION CLEARWAY RX CATHETER

K-Number: K061680 · 2006-12-15

ApplicantAtrium Medical Corp.
Decision Date2006-12-15
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ATRIUM MEDICAL CORPORATION CLEARWAY RX CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Atrium Medical Corp.. It received FDA 510(k) clearance on 2006-12-15 under 510(k) number K061680. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ATRIUM MEDICAL CORPORATION CLEARWAY RX CATHETER?

ATRIUM MEDICAL CORPORATION CLEARWAY RX CATHETER is a medical device that received FDA 510(k) clearance on 2006-12-15. The listed applicant is Atrium Medical Corp.. The 510(k) number is K061680.

When did ATRIUM MEDICAL CORPORATION CLEARWAY RX CATHETER receive FDA 510(k) clearance?

ATRIUM MEDICAL CORPORATION CLEARWAY RX CATHETER received FDA 510(k) clearance on 2006-12-15, under 510(k) number K061680.

Who is the listed applicant for ATRIUM MEDICAL CORPORATION CLEARWAY RX CATHETER?

The FDA 510(k) record lists Atrium Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ATRIUM MEDICAL CORPORATION CLEARWAY RX CATHETER?

The FDA product code for ATRIUM MEDICAL CORPORATION CLEARWAY RX CATHETER is DQY.

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Other records listing Atrium Medical Corp. as applicant

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.

K130131EDRAIN CHEST DRAINAGE SYSTEMK122138ATRIUM FLIXENE IFG VASCULAR GRAFTK121070C-QUR RPM MESHK113112CLEARWAY RX NB CATHETERK102596ATRIUM GRADUATED WALL FLIXENE AX-BIFEM GRAFTK093431CLEARWAY OTW MODEL 85912

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Related Devices (Code: DQY)

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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