Home / 510(k) Clearances / K874771

510(k) K874771

ANGIOMED INTRODUCING SETS by Angiomed U.S., Inc. — Product Code DWB

K874771 is an FDA 510(k) premarket notification submitted by Angiomed U.S., Inc. for the device "ANGIOMED INTRODUCING SETS". The FDA issued a decision of Substantially Equivalent on January 12, 1988. The device falls under product code DWB (Pump, Blood, Cardiopulmonary Bypass, Roller Type), a Class II device regulated under 21 CFR 870.4370. Angiomed U.S., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 1988
Date Received
November 19, 1987
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 Angiomed U.S., Inc.

  • K874585 — ANGIOMED OSTY-CUT BONE BIOPSY NEEDLE (December 2, 1987)
  • K864225 — ANGIOMED URETERAL D&M SETS/URETEROSCOPY GUID STENT (January 30, 1987)
  • K863386 — VESICO SUPRAPUBIC BLADDER DRAINAGE & EXCHANGE SETS (October 24, 1986)
  • K862805 — ANGIOMED VAC-U-CUT BIOPSY NEEDLE (September 29, 1986)
  • K863446 — ANGIOMED HIGH PRESSURE CONNECTORS (September 23, 1986)
  • K854910 — ANGIOFLOW (July 17, 1986)
  • K854912 — ANGIOMED GUIED WIRES (April 16, 1986)
  • K854908 — UROFLEX (March 14, 1986)
  • K855076 — ANGIOMED URETER DIATION SETS (March 11, 1986)
  • K855142 — ANGIOMED PERCUTANEOUS TRANSHEPATIC CHOLANGIOGTAPHY (March 11, 1986)

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)
  • 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)

FDA data resources