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FDA 510(k)

Pounce Thrombectomy System

K-Number: K211492 · 2021-07-30

ApplicantSurmodics,Inc.
Decision Date2021-07-30
Product CodeQEW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Pounce Thrombectomy System is the device name listed in this FDA 510(k) record. The listed applicant is Surmodics,Inc.. It received FDA 510(k) clearance on 2021-07-30 under 510(k) number K211492. The device is classified under product code QEW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Pounce Thrombectomy System?

Pounce Thrombectomy System is a medical device that received FDA 510(k) clearance on 2021-07-30. The listed applicant is Surmodics,Inc.. The 510(k) number is K211492.

When did Pounce Thrombectomy System receive FDA 510(k) clearance?

Pounce Thrombectomy System received FDA 510(k) clearance on 2021-07-30, under 510(k) number K211492.

Who is the listed applicant for Pounce Thrombectomy System?

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

What is the FDA product code for Pounce Thrombectomy System?

The FDA product code for Pounce Thrombectomy System is QEW.

Other records listing Surmodics,Inc. 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.

K252227Pounce(TM) SheathPMA P210025Drug-Eluting Peripheral Transluminal Angioplasty CatheterK241362Pounce XL Thrombectomy System (PTS-1011-7F135)K232647MicrocatheterK231828Pounce™ SheathK231022Pounce™ Thrombectomy System

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Related Devices (Code: QEW)

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.

K261523Vertex™ Thrombectomy SystemJupiter EndovascularK260599INDIGO® Aspiration System – INDIGO LinkPenumbra, Inc.K260028CLEANER™ Vac Thrombectomy System, CLEANER™ Vac Aspiration Catheter with Handpiece, CLEANER™ Vac Aspiration CanisterArgon Medical Devices, Inc.K251949INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINKPenumbra, Inc.K253730RoVo Mechanical Thrombectomy SystemVerge Medical, Inc.K251207Sangria™ Thrombectomy SystemAvantec Vascular Corporation

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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