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FDA 510(k)

Protaryx Transseptal Puncture Device (PTX2-001)

K-Number: K260839 · 2026-04-10

ApplicantProtaryx Medical, Inc.
Decision Date2026-04-10
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Protaryx Transseptal Puncture Device (PTX2-001) is the device name listed in this FDA 510(k) record. The listed applicant is Protaryx Medical, Inc.. It received FDA 510(k) clearance on 2026-04-10 under 510(k) number K260839. 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 Protaryx Transseptal Puncture Device (PTX2-001)?

Protaryx Transseptal Puncture Device (PTX2-001) is a medical device that received FDA 510(k) clearance on 2026-04-10. The listed applicant is Protaryx Medical, Inc.. The 510(k) number is K260839.

When did Protaryx Transseptal Puncture Device (PTX2-001) receive FDA 510(k) clearance?

Protaryx Transseptal Puncture Device (PTX2-001) received FDA 510(k) clearance on 2026-04-10, under 510(k) number K260839.

Who is the listed applicant for Protaryx Transseptal Puncture Device (PTX2-001)?

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

What is the FDA product code for Protaryx Transseptal Puncture Device (PTX2-001)?

The FDA product code for Protaryx Transseptal Puncture Device (PTX2-001) is DYB.

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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