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510(k) K951089

SCIMED GATEWAY PLUS by Scimed Life Systems, Inc. — Product Code DTL

K951089 is an FDA 510(k) premarket notification submitted by Scimed Life Systems, Inc. for the device "SCIMED GATEWAY PLUS". The FDA issued a decision of Substantially Equivalent on May 31, 1995. The device falls under product code DTL (Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4290. Scimed Life Systems, Inc. has 108 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
May 31, 1995
Date Received
Mar 9, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4290
Review Panel
CV
Submission Type
510(k) Exempt

Other clearances by Scimed Life Systems, Inc.

  • K974241 — SCIMED INFORMER PRESSURE WIRE SYSTEM (Nov 12, 1998)
  • K981788 — SCIMED 6 FRENCH WISEGUIDE GUIDE CATHETER (Aug 18, 1998)
  • K980360 — SCIMED QUEST FLOPPY AND MODERATE SUPPORT GUIDE WIRES (Apr 29, 1998)
  • K974559 — SCIMED 6 FRENCH IMPULSE ANGIOGRAPHIC CATHETERS (Feb 23, 1998)
  • K974684 — SCIMED 7 FRENCH WISEGUIDE GUIDE CATHETER (Feb 19, 1998)
  • K973945 — LUGE GUIDE WIRE (Jan 12, 1998)
  • K970823 — SCIMED 8 FRENCH WISEGUIDE GUIDE CATHETER (Jun 3, 1997)
  • K964551 — CHOICE SUPER SUPPORT PTCA GUIDE WIRE, CHOICE PLUS SUPER SUPPORT PTCA GUIDE WIRE… (May 21, 1997)
  • K970244 — SCIMED CHOICE FAMILY OF PTCA GUIDE WIRES (Mar 28, 1997)
  • K965023 — CHOICE PT PLUS PTCA GUIDE WIRE AND CHOICE PT VISION PTCA GUIDE WIRE (Mar 4, 1997)

Other clearances for product code DTL

  • K152528 — Attachable Cath Lab Hemostasis Valve (Dec 2, 2015)
  • K143429 — Passage Hemostasis Valve (Dec 22, 2014)
  • K140475 — ROTATING ADAPTERS (Apr 16, 2014)
  • K131124 — COLIGN (Aug 28, 2013)
  • K123448 — AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH BALANCE BIOSURFACE, AFFINITY FLEXIBLE… (Dec 13, 2012)
  • K122811 — CONNECTOR COMPONENTS WITH BALANCE BIOSURFACE (Oct 12, 2012)
  • K122301 — GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVE (Sep 7, 2012)
  • K120069 — MEDLINE STOPCOCK AND MANIFOLD (Apr 3, 2012)
  • K113148 — E-PASS (Feb 28, 2012)
  • K113845 — TUBING, CONMNECTORS, AND ACCESSORIES WIT BALANCE BIOSURFACE (Jan 25, 2012)

FDA data resources

Source: FDA 510(k) database entry for K951089. Report a data issue: hello@regdatalab.com.