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510(k) K021004

VALVED PEELABLE INTRODUCER by Medamicus, Inc. — Product Code DYB

K021004 is an FDA 510(k) premarket notification submitted by Medamicus, Inc. for the device "VALVED PEELABLE INTRODUCER". The FDA issued a decision of Substantially Equivalent on June 6, 2002. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Medamicus, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 2002
Date Received
March 28, 2002
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 Medamicus, Inc.

  • K040150 — MODIFICATION TO MEDAMICUS FLOWGUARD PEELABLE INTRODUCER (February 18, 2004)
  • K030905 — MEDAMICUS FLOWGUARD PEELABLE INTRODUCER (April 9, 2003)
  • K022689 — MODIFICATION TO MEDAMICUS AXIA RSN (August 23, 2002)
  • K020563 — MEDAMICUS AXIA RSN (May 21, 2002)
  • K013120 — PERCUTANEOUS INTRODUCER SET, MODEL 042294 AND KIT MODEL 3550-18 (January 24, 2002)
  • K011085 — GUIDEWIRE INTRODUCER SAFETY NEEDLE (July 9, 2001)
  • K000824 — PERCUTANEOUS INTRODUCER, MODEL 10383-XXX (April 13, 2000)
  • K994097 — MEDAMICUS EPIDURAL INTRODUCER (March 1, 2000)
  • K990705 — MEDAMICUS COAXIAL INTRODUCER KIT, 10330-XXX, BOSTON SCIENTIFIC COAXIAL DILATOR S (June 28, 1999)
  • K965167 — PERCUTANEOUS VENOUS INTRODUCER 10264 (July 25, 1997)

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