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510(k) K882238

VESSEL DILATOR AND INTRODUCER SHEATH by Ideal Medical, Inc. — Product Code DRE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 1988
Date Received
May 27, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dilator, Vessel, For Percutaneous Catheterization
Device Class
Class II
Regulation Number
870.1310
Review Panel
CV
Submission Type

Other clearances by Ideal Medical, Inc.

  • K944067 — PEANUT WAND, MODIFICATION (December 8, 1994)
  • K931115 — HATCHER STONE-EMBOLIS EXTRACTOR (August 20, 1993)
  • K926335 — IDEAS PEANUT WAND (June 24, 1993)
  • K922161 — GRICE SOFT TISSUE BIOPSY KIT (October 13, 1992)
  • K921922 — GRICE LAPAROSCOPIC SUTURING NEEDLE (July 8, 1992)
  • K915175 — REDDICK RETRACTOR (April 29, 1992)
  • K914880 — DUAL BALLOON EMBOLECTOMY CATHETER (March 16, 1992)
  • K913602 — IDEAS' PORT (January 2, 1992)
  • K914913 — GRICE FOOT PEDAL CONTROL/REDDICK IRRI/ASPIR SYST (December 31, 1991)
  • K912540 — CONTOUR-PORT (August 23, 1991)

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