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510(k) K813035

POLYSTAN VERTICLUDE BLOOD PUMP by Advocacy International, Ltd. — Product Code DWB

K813035 is an FDA 510(k) premarket notification submitted by Advocacy International, Ltd. for the device "POLYSTAN VERTICLUDE BLOOD PUMP". The FDA issued a decision of Substantially Equivalent on November 27, 1981. The device falls under product code DWB (Pump, Blood, Cardiopulmonary Bypass, Roller Type), a Class II device regulated under 21 CFR 870.4370. Advocacy International, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 27, 1981
Date Received
October 28, 1981
Clearance Type
Traditional
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 Advocacy International, Ltd.

  • K874027 — LIPASE UV [TOYO] (May 27, 1988)
  • K873792 — SEPACELL R-500 AND SEPACELL R-500A (January 19, 1988)
  • K855251 — MODIFICATION ASAHI NEW PAN-SERIES HEMOFILTERS (February 4, 1986)
  • K855212 — ASAHI AM SERIES DIALYZERS (January 21, 1986)
  • K854259 — SEPACELL R-500 & SEPACELL R-500A (January 8, 1986)
  • K842103 — TOYO JOZO URIC ACID TEST (August 12, 1984)
  • K842104 — TOYO JOZO G-GTP TEST (August 10, 1984)
  • K830183 — ASAHI HOLLOW FIBER KIDNEYS NR SERIES (March 17, 1983)
  • K830231 — ASAHI HOLLOW FIBER KIDNEYS, AM-SERIES (March 17, 1983)
  • K823733 — EIKEN KIZAI ARTIFICIAL KIDNEY BLOOD CIR (January 14, 1983)

Other clearances for product code DWB

  • K162843 — Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roll (November 17, 2016)
  • 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)
  • K953904 — SARNS 9000 UNIVERSAL ROLLER PUMP (April 19, 1996)
  • K953901 — SARNS 800 ROLLER PUMP (April 19, 1996)
  • K955038 — STOCKERT S3 DOUBLE HEAD PUMP MODULE (February 21, 1996)

FDA data resources