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510(k) K981061

INTRAVASCULAR RETRIEVAL DEVICE by Med Institute, Inc. — Product Code GCC

K981061 is an FDA 510(k) premarket notification submitted by Med Institute, Inc. for the device "INTRAVASCULAR RETRIEVAL DEVICE". The FDA issued a decision of Substantially Equivalent on May 26, 1998. The device falls under product code GCC (Dilator, Catheter), a Class I device regulated under 21 CFR 878.4200. Med Institute, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 1998
Date Received
March 23, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dilator, Catheter
Device Class
Class I
Regulation Number
878.4200
Review Panel
SU
Submission Type

Other clearances by Med Institute, Inc.

  • K990034 — WILSON-COOK COLONIC Z-STENT (April 17, 2000)
  • K982507 — MINI POLYURETHANE CATHETER (September 16, 1998)
  • K964001 — SWARTZ DOPPLER FLOW PROBE AND MONITOR SYSTEM (April 17, 1998)
  • K971140 — VITAL-PORT INFUSION PAL (November 17, 1997)
  • K970442 — TARGET VITAL-PORT VASCULAR ACCESS SYSTEM (April 30, 1997)
  • K945586 — FLEXIBLE DILATING SHEATH (April 4, 1997)
  • K960698 — NON-CORING NEEDLE (April 15, 1996)
  • K941228 — ENDOLUMINAL ACCESS TUBE (September 27, 1995)
  • K951077 — VITAL-PORT PETIET POLYSULFONE VASCULAR ACCESS SYSTEM (July 31, 1995)
  • K951076 — VITAL-PORT PETITE DUAL VASCULAR ACCESS SYSTEM (June 13, 1995)

Other clearances for product code GCC

  • K922354 — BYRD TELESCOPING STAINLESS STEEL DILAT SHEATH SET (July 30, 1992)
  • K902502 — BYRD STAINLESS STEEL DILATOR (August 7, 1990)
  • K893480 — BYRD EXTRACTOR SET (June 23, 1989)
  • K820865 — VAN-TEC FASCIAL DILATOR (May 5, 1982)

FDA data resources