Home / 510(k) Clearances / K931218

510(k) K931218

INTROPEEL V by Menlo Care, Inc. — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 22, 1993
Date Received
March 10, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Menlo Care, Inc.

  • K964447 — PICC CATHETER/MIDLINE CATHETER (April 16, 1997)
  • K951620 — MIDMARK MIDLINE CATHETER (April 4, 1996)
  • K945521 — CENTERMARK(R) PICC INSERTION TRAY LANDMARK(R) MIDLINE CATHETER PREP TRAY (April 6, 1995)
  • K950737 — LANDMARK MIDLINE CATHETER (March 29, 1995)
  • K944968 — LANDMARK MIDLINE CATHETER (March 29, 1995)
  • K943893 — PERCUTANEOUS GRAINAGE CATHETER (March 7, 1995)
  • K943143 — BILIARY STENT (February 28, 1995)
  • K930048 — SAFE-PICC CATHETER (May 12, 1994)
  • K933941 — MENLO CARE URINARY DIVERSION STENT (March 31, 1994)
  • K940127 — CENTERMARK SECURING WINGS (February 9, 1994)

Other clearances for product code DYB

  • K260163 — AuST CSP Introducer (February 19, 2026)
  • K254236 — Peel-Away Introducer Sheath (February 9, 2026)
  • K253652 — Genie MAX Large Bore Introducer Sheath (January 22, 2026)
  • K252508 — Intri26 Introducer Sheath (December 17, 2025)
  • K253741 — V•Stick™ Vascular Access Set (December 15, 2025)
  • K252309 — PerQseal Introducers (October 23, 2025)
  • K251838 — Introducer Sheath Set (October 21, 2025)
  • K252766 — 14Fr Low Profile Introducer Kit (October 8, 2025)
  • K252441 — Primero Safe Access System (September 29, 2025)
  • K252227 — Pounce(TM) Sheath (September 24, 2025)