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510(k) K241042

SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198) by Pressure Products Medical Device Manufacturing, LLC — Product Code DRC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 17, 2024
Date Received
April 17, 2024
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Trocar
Device Class
Class II
Regulation Number
870.1390
Review Panel
CV
Submission Type

Other clearances by Pressure Products Medical Device Manufacturing, LLC

  • K253799 — SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135 (March 13, 2026)
  • K221707 — SafeSept® Transseptal Guidewire (SS-140) (September 14, 2022)
  • K210328 — SafeSept Blunt Needle (March 5, 2021)
  • K181031 — TSI Transseptal Introducer (October 26, 2018)
  • K172950 — TSN Transseptal Needle (February 21, 2018)
  • K172934 — Needle Free Transseptal Cannula (February 16, 2018)
  • K172893 — SafeSept Needle Free Transseptal Guidewire (December 21, 2017)
  • K170671 — SafeSept Transseptal Guidewire (October 20, 2017)

Other clearances for product code DRC

  • K240246 — Accusafe Transseptal Guidewire (GTR31180, GTR31230) (July 26, 2024)
  • K221707 — SafeSept® Transseptal Guidewire (SS-140) (September 14, 2022)
  • K212625 — PathBuilder Transseptal Needle (March 23, 2022)
  • K210328 — SafeSept Blunt Needle (March 5, 2021)
  • K172950 — TSN Transseptal Needle (February 21, 2018)
  • K172934 — Needle Free Transseptal Cannula (February 16, 2018)
  • K172893 — SafeSept Needle Free Transseptal Guidewire (December 21, 2017)
  • K170671 — SafeSept Transseptal Guidewire (October 20, 2017)
  • K132943 — INTRACARDIC CATHETER INTRODUCER KIT AND TRANSSEPTAL NEEDLE (August 29, 2014)
  • K130843 — SAFESEPT NEEDLE FREE TRANSSEPTAL TROCAR GUIDEWIRE (January 8, 2014)