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510(k) K260839

Protaryx Transseptal Puncture Device (PTX2-001) by Protaryx Medical, Inc. — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 2026
Date Received
March 13, 2026
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Introducer, Catheter
Device Class
Class II
Regulation Number
870.1340
Review Panel
CV
Submission Type

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