Home / 510(k) Clearances / K110193

510(k) K110193

FEMOSTOP PLYS, FEMOSTOP HD, FEMOSTOP COMPRESSION ARCH; FEMOSTOP II PLUS SET; FEMOSTOP II PLUS ARCH, BILATERAL ADAPTER; F by St. Jude Medical Systems AB — Product Code DXC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 2011
Date Received
January 24, 2011
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clamp, Vascular
Device Class
Class II
Regulation Number
870.4450
Review Panel
CV
Submission Type

Other clearances by St. Jude Medical Systems AB

  • K140466 — PRESSUREWIRE: AERIS AGILE TIP, AERIS AGILE TIP 300, CERTUS AGILE TIP, CERTUS AGI (November 13, 2014)
  • K133587 — PRESSUREWIRE AERIS AGILE TIP; PRESSUREWIRE AERIS AGILE TIP 300 (December 20, 2013)
  • K131452 — PRESSUREWIRE; CERTUS, CERTUS 300, AERIS, AERIS 300 (September 5, 2013)
  • K111854 — AO USB RECEIVER, WI-BOX, WI-BOX PSU KIT, WI-BOX XPRESS CABLE, PW USB RECEIVER (October 21, 2011)

Other clearances for product code DXC

  • K243627 — Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction (December 31, 2025)
  • K253070 — Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRA (November 20, 2025)
  • K232577 — Radial Compression Device (January 18, 2024)
  • K230281 — PICOCLAMP (October 23, 2023)
  • K221661 — Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S) (March 3, 2023)
  • K230248 — VIOLA (February 28, 2023)
  • K222182 — Radial Artery Compression Tourniquets (January 4, 2023)
  • K221843 — GEM Biover Microvascular Clamps (September 14, 2022)
  • K213531 — TR BAND Radial Compression Device (December 20, 2021)
  • K210681 — SiteSeal SV (April 6, 2021)