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510(k) K012763

SORIN BIOMEDICA SMART BCD VANGUARD,SURFACE MODIFIED BLOOD CARDIOPLEGIA SYSTEM by Cobe Cardiovascular, Inc. — Product Code DRT

K012763 is an FDA 510(k) premarket notification submitted by Cobe Cardiovascular, Inc. for the device "SORIN BIOMEDICA SMART BCD VANGUARD,SURFACE MODIFIED BLOOD CARDIOPLEGIA SYSTEM". The FDA issued a decision of Substantially Equivalent on November 15, 2001. The device falls under product code DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)), a Class II device regulated under 21 CFR 870.2300. Cobe Cardiovascular, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 2001
Date Received
August 17, 2001
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Device Class
Class II
Regulation Number
870.2300
Review Panel
CV
Submission Type

Other clearances by Cobe Cardiovascular, Inc.

  • K050111 — SMARXT BMR 1900 CLOSED VENOUS RESERVOIR BAG (March 8, 2005)
  • K042473 — COBE ANGEL WHOLE BLOOD SEPARATION SYSTEM (November 19, 2004)
  • K040184 — DIDECO MICRO 40 PH.I.S.I.O. ADULT ARTERIAL FILTER (February 26, 2004)
  • K033641 — SMARXT VVR4000I PLUS FILTERED HARDSHELL VENOUS RESERVOIR, MODEL 439914800 (December 11, 2003)
  • K030462 — COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC, MODEL 050300700 (March 6, 2003)
  • K021830 — SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM (July 2, 2002)
  • K011835 — COBE REVOLUTION (February 12, 2002)
  • K013480 — COBE SMARXT OPTIMIN SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATOR (November 16, 2001)
  • K001509 — STOCKERT V172 SERIES VENOUS FEMORAL CANNULAE (October 26, 2001)
  • K012898 — MODIFICATION TO: CSC14 BLOOD CARDIOPLEGIA SYSTEM (September 17, 2001)

Other clearances for product code DRT

  • K261286 — The Circadia C300 System (C300) (May 20, 2026)
  • K252676 — The Circadia C300 System (C300) (February 3, 2026)
  • K253388 — Sleepiz One+ (Model 2.5) (January 28, 2026)
  • K251364 — Sleepiz One+ (2.5) (July 29, 2025)
  • K234003 — The Circadia C200 System (May 30, 2024)
  • K232354 — Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central (March 22, 2024)
  • K231733 — Neteera 130H-Plus Vital Sign Monitoring Sensor (February 9, 2024)
  • K223163 — Sleepiz One+ (August 18, 2023)
  • K212143 — Neteera 130H/131H Vital Sign Monitoring Sensor (September 28, 2022)
  • K202138 — Cardiac Trigger Monitor (May 14, 2021)

FDA data resources