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510(k) K162843

Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump for the Terumo Advanced Perfusion System 1 by Terumo Cardiovascular Systems Corporation — Product Code DWB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 17, 2016
Date Received
October 11, 2016
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Blood, Cardiopulmonary Bypass, Roller Type
Device Class
Class II
Regulation Number
870.4370
Review Panel
CV
Submission Type

Other clearances by Terumo Cardiovascular Systems Corporation

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  • K200091 — Capiox iCP Centrifugal Pump (November 18, 2021)
  • K182110 — CDI Blood Parameter Monitoring System 550 (November 2, 2018)
  • K180950 — Terumo Capiox NX19 Oxygenator with Reservoir (east Orientation), Terumo Capiox N (June 22, 2018)
  • K172071 — Terumo Capiox NX19 Oxygenator with Reservoir (east orientation ), Terumo Capiox (March 29, 2018)
  • K172220 — Advanced Perfusion System 1 (August 17, 2017)
  • K163531 — Advanced Perfusion System 1 (June 7, 2017)
  • K160206 — VirtuoSaph Plus Endoscopic Vessel Harvesting System (April 21, 2016)
  • K153376 — Advanced Perfusion System 1 (December 16, 2015)

Other clearances for product code DWB

  • K131618 — LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1; LARGE (6) ROLLER P (September 27, 2013)
  • K112587 — ADVANCED PERFUSION SYSTEM 1 (APS1) TUBE CLAMP ASSEMBLY, ROLLER PUMP 6 INCH CLASS (December 19, 2011)
  • K973237 — CSS-CARDIOPLEGIA SAFETY SYSTEM (April 27, 1998)
  • K972321 — S3 MAST PUMP (February 27, 1998)
  • K971520 — S3 CYCLIC RPM CONTROL (September 10, 1997)
  • K960974 — COBE CENTURY PERFUSION PUMP (July 14, 1997)
  • K953901 — SARNS 800 ROLLER PUMP (April 19, 1996)
  • K953904 — SARNS 9000 UNIVERSAL ROLLER PUMP (April 19, 1996)
  • K955038 — STOCKERT S3 DOUBLE HEAD PUMP MODULE (February 21, 1996)
  • K890904 — MODIFIED STOCKERT-SHILEY CAPS MULTI. ROLLER PUMP (April 12, 1989)