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510(k) K982538

BELMONT PORTABLE BALLOON PUMP, BARD TRANSACT IABP by Belmont Instrument Corp. — Product Code DSP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 2, 1998
Date Received
July 21, 1998
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Balloon, Intra-Aortic And Control
Device Class
Class II
Regulation Number
870.3535
Review Panel
CV
Submission Type

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  • K090508 — THE BELMONT BUDDY LITE FLUID WARMER (March 26, 2009)
  • K090089 — BELMONT HYPERTHERMIA PUMP (February 12, 2009)
  • K070654 — HYPERTHERMIA PUMP (June 8, 2007)
  • K062774 — BELMONT BUDDY PLUS FLUID WARMER (October 19, 2006)
  • K052547 — BELMONT BUDDY FLUID WARMER (October 13, 2005)
  • K032778 — LARGE VOLUME FLUID RESERVOIR (September 22, 2003)
  • K032674 — BELMONT FLUID MANAGEMENT SYSTEM, MODEL FMS2000 (September 16, 2003)

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