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510(k) K855049

MODIFIED MODEL SC4000(F) CARDIOTOMY RESERVOIR by Scimed Life Systems, Inc. — Product Code DTP

K855049 is an FDA 510(k) premarket notification submitted by Scimed Life Systems, Inc. for the device "MODIFIED MODEL SC4000(F) CARDIOTOMY RESERVOIR". The FDA issued a decision of Substantially Equivalent on Feb 26, 1986. The device falls under product code DTP (Defoamer, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4230. Scimed Life Systems, Inc. has 108 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Feb 26, 1986
Date Received
Dec 17, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Defoamer, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4230
Review Panel
CV
Submission Type
510(k)

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 DTP

  • K101186 — AFFINITY VARD SUB-ASSEMBLY FOR CPS (CARMEDA COATED), PURGELINE (UNCOATED)… (Sep 3, 2010)
  • K082412 — VENOUS BUBBLE TRAP, MODEL VBT 160; VENOUS BUBBLE TRAP WITH BIOLINE COATING… (Nov 10, 2008)
  • K004046 — COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR, COBE SMARXT VVR 4000 FILTERED… (Apr 26, 2001)
  • K002591 — COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR (Sep 13, 2000)
  • K990514 — MODIFICATION OF BARD QUANTUM CVR, MODEL H-6770VR (Mar 9, 1999)
  • K984322 — DIDECO D920, LILLIPUT 1 TWIN RESERVOIR (Mar 2, 1999)
  • K962726 — BARD QUANTUM CVR (Oct 30, 1996)
  • K941654 — SARNS FILTERED VENOUS RESERVIOR MODIFICATION (Jul 26, 1994)
  • K933496 — MAXIMA FILTERED HARDSHELL RESERVIOR (Oct 15, 1993)
  • K912915 — SARNS NON-FILTERED VENOUS RESERVOIR (Sep 25, 1991)

FDA data resources

Source: FDA 510(k) database entry for K855049. Report a data issue: hello@regdatalab.com.