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FDA 510(k)

CLEARWAY RX NB CATHETER

K-Number: K113112 · 2011-11-17

ApplicantAtrium Medical Corp.
Decision Date2011-11-17
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CLEARWAY RX NB 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 2011-11-17 under 510(k) number K113112. 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 CLEARWAY RX NB CATHETER?

CLEARWAY RX NB CATHETER is a medical device that received FDA 510(k) clearance on 2011-11-17. The listed applicant is Atrium Medical Corp.. The 510(k) number is K113112.

When did CLEARWAY RX NB CATHETER receive FDA 510(k) clearance?

CLEARWAY RX NB CATHETER received FDA 510(k) clearance on 2011-11-17, under 510(k) number K113112.

Who is the listed applicant for CLEARWAY RX NB 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 CLEARWAY RX NB CATHETER?

The FDA product code for CLEARWAY RX NB 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 MESHK102596ATRIUM GRADUATED WALL FLIXENE AX-BIFEM GRAFTK093431CLEARWAY OTW MODEL 85912K100076ATRIUM C-QUR OVT MESH

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Related Devices (Code: DQY)

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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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