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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 a medical device manufactured by Protaryx Medical, Inc.. It received FDA 510(k) clearance on 2026-04-10 under approval 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. It is manufactured by Protaryx Medical, Inc.. The 510(k) number is K260839.

When was Protaryx Transseptal Puncture Device (PTX2-001) approved by the FDA?

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

What company makes Protaryx Transseptal Puncture Device (PTX2-001)?

Protaryx Transseptal Puncture Device (PTX2-001) is manufactured by Protaryx Medical, Inc..

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.

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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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