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FDA 510(k)

Occlusion Perfusion Catheter

K-Number: K153488 · 2016-02-25

ApplicantAdvanced Catheter Therapies, Inc.
Decision Date2016-02-25
Product CodeQEY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Occlusion Perfusion Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Catheter Therapies, Inc.. It received FDA 510(k) clearance on 2016-02-25 under 510(k) number K153488. The device is classified under product code QEY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Occlusion Perfusion Catheter?

Occlusion Perfusion Catheter is a medical device that received FDA 510(k) clearance on 2016-02-25. The listed applicant is Advanced Catheter Therapies, Inc.. The 510(k) number is K153488.

When did Occlusion Perfusion Catheter receive FDA 510(k) clearance?

Occlusion Perfusion Catheter received FDA 510(k) clearance on 2016-02-25, under 510(k) number K153488.

Who is the listed applicant for Occlusion Perfusion Catheter?

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

What is the FDA product code for Occlusion Perfusion Catheter?

The FDA product code for Occlusion Perfusion Catheter is QEY.

Related Devices (Code: QEY)

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.

K260149Versus™ Catheter (VS110-9NB)Liquet Medical, Inc.K251318VariFuse Adjustable Infusion CatheterArgon Medical Devices, Inc.K241851Versus™ Catheter (VS110-8B)Liquet Medical, Inc.K231653BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular CatheterThrombolex, Inc.K222095BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101Thrombolex, Inc.K220866EKOS+ Endovascular DeviceBoston Scientific

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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