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FDA 510(k)

Pounce(TM) Sheath

K-Number: K252227 · 2025-09-24

ApplicantSurmodics,Inc.
Decision Date2025-09-24
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Pounce(TM) Sheath is the device name listed in this FDA 510(k) record. The listed applicant is Surmodics,Inc.. It received FDA 510(k) clearance on 2025-09-24 under 510(k) number K252227. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Pounce(TM) Sheath?

Pounce(TM) Sheath is a medical device that received FDA 510(k) clearance on 2025-09-24. The listed applicant is Surmodics,Inc.. The 510(k) number is K252227.

When did Pounce(TM) Sheath receive FDA 510(k) clearance?

Pounce(TM) Sheath received FDA 510(k) clearance on 2025-09-24, under 510(k) number K252227.

Who is the listed applicant for Pounce(TM) Sheath?

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(TM) Sheath?

The FDA product code for Pounce(TM) Sheath is DYB.

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.

PMA P210025Drug-Eluting Peripheral Transluminal Angioplasty CatheterK241362Pounce XL Thrombectomy System (PTS-1011-7F135)K232647MicrocatheterK231828Pounce™ SheathK231022Pounce™ Thrombectomy SystemK221886Sublime Microcatheter

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Related Devices (Code: DYB)

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.

K253526NAMIC Dilator and SheathMedline Industries, LPK261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04)Hartman Medical Group, LLCK261242SimplGuidePendracareK261950Health Line Tearaway IntroducerHealth Line International CorporationK261492FieldFlex Steerable SheathCenterPoint Systems, LLCK260606Echo Large Bore Introducer SheathEcho Medical, LLC

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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