Home / 510(k) Clearances / K091954

510(k) K091954

MICRO-STICK SET by Medcomp — Product Code DYB

K091954 is an FDA 510(k) premarket notification submitted by Medcomp for the device "MICRO-STICK SET". The FDA issued a decision of Substantially Equivalent on January 8, 2010. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Medcomp has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 2010
Date Received
July 1, 2009
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 Medcomp

  • K130889 — SPLIT CATH RG (April 28, 2014)
  • K123292 — T3 (June 11, 2013)
  • K102966 — 2.6F X 20CM VASCU-PICC, 2.6F X 50CM VASCU-PICC (December 21, 2010)
  • K091953 — PRO-PICC (September 16, 2009)
  • K092347 — PRO-PICC CT (September 16, 2009)
  • K090394 — VALVED TEARWAY INTRODUCER (September 1, 2009)
  • K091586 — VASCU-PICC AND MIDLINE CATHETERS, SINGLE, DOUBLE AND TRIPLE LUMEN (July 23, 2009)
  • K091466 — 1.9F X 20CM VASCU-PICC, 1.9F X 50CM VASCU-PICC, MODEL VPI.9S20, VPI.9S50 (June 17, 2009)
  • K081775 — THE MEDCOMP .010 VASCULAR GUIDEWIRES (March 25, 2009)
  • K081904 — PRO-PICC (BASIC TRAY, LONG WIRE TRAY, BASIC NURSING TRAY, FULL NURSING TRAY) (September 23, 2008)

Other clearances for product code DYB

  • K261529 — Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Mic (July 6, 2026)
  • K261242 — SimplGuide (June 25, 2026)
  • K261950 — Health Line Tearaway Introducer (June 22, 2026)
  • K261492 — FieldFlex Steerable Sheath (June 5, 2026)
  • K260606 — Echo Large Bore Introducer Sheath (April 29, 2026)
  • K254248 — Introducer Sheath Set (April 23, 2026)
  • K254279 — Edwards eSheath+ introducer set (April 17, 2026)
  • K260091 — Aventus Introducer Sheath (April 13, 2026)
  • K260839 — Protaryx Transseptal Puncture Device (PTX2-001) (April 10, 2026)
  • K260942 — AuST Steerable Sheath (April 7, 2026)

FDA data resources