FDA 510(k)

Pounce XL Thrombectomy System (PTS-1011-7F135)

K-Number: K241362 · 2024-09-11

Decision Date2024-09-11

Product CodeQEW

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Pounce XL Thrombectomy System (PTS-1011-7F135) is the device name listed in this FDA 510(k) record. The listed applicant is Surmodics,Inc.. It received FDA 510(k) clearance on 2024-09-11 under 510(k) number K241362. 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 XL Thrombectomy System (PTS-1011-7F135)?

Pounce XL Thrombectomy System (PTS-1011-7F135) is a medical device that received FDA 510(k) clearance on 2024-09-11. The listed applicant is Surmodics,Inc.. The 510(k) number is K241362.

When did Pounce XL Thrombectomy System (PTS-1011-7F135) receive FDA 510(k) clearance?

Pounce XL Thrombectomy System (PTS-1011-7F135) received FDA 510(k) clearance on 2024-09-11, under 510(k) number K241362.

Who is the listed applicant for Pounce XL Thrombectomy System (PTS-1011-7F135)?

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 XL Thrombectomy System (PTS-1011-7F135)?

The FDA product code for Pounce XL Thrombectomy System (PTS-1011-7F135) 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) Sheath PMA P210025Drug-Eluting Peripheral Transluminal Angioplasty Catheter K232647Microcatheter K231828Pounce™ Sheath K231022Pounce™ Thrombectomy System K221886Sublime Microcatheter

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Related Devices (Code: QEW)

K261523Vertex™ Thrombectomy SystemJupiter Endovascular K260599INDIGO® 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.