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510(k) K915577

IMPRAFLO POSTOPERATIVE AUTOTRANSFUSION DEVICE by Impra, Inc. — Product Code CAR

K915577 is an FDA 510(k) premarket notification submitted by Impra, Inc. for the device "IMPRAFLO POSTOPERATIVE AUTOTRANSFUSION DEVICE". The FDA issued a decision of Substantially Equivalent on March 11, 1992. The device falls under product code CAR (Monitor, Spinal-Fluid Pressure, Electrically Powered), a Class II device regulated under 21 CFR 880.2460. Impra, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 1992
Date Received
December 13, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Spinal-Fluid Pressure, Electrically Powered
Device Class
Class II
Regulation Number
880.2460
Review Panel
HO
Submission Type

Other clearances by Impra, Inc.

  • K004012 — IMPRA CARBOFLO EPTFE VASCULAR GRAFTS (May 14, 2001)
  • K004011 — IMPRA CARBOFLO VASCULAR GRAFT, IMPRA CARBOFLO VASCULAR GRAFTS FOR A-V ACCESS (March 27, 2001)
  • K991027 — BI-DIRECTIONAL TUNNELER (April 22, 1999)
  • K983769 — DISTAFLO BYPASS GRAFT (December 15, 1998)
  • K983861 — DISTAFLO BYPASS GRAFT (November 24, 1998)
  • K983064 — IMPRA HIGH POROSITY GRAFT (November 19, 1998)
  • K981079 — VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAFLO VASCULAR GRAFT (May 7, 1998)
  • K981076 — VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAFLO VASCULAR GRAFT (May 7, 1998)
  • K971192 — IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT (April 15, 1997)
  • K964877 — IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT (March 20, 1997)

Other clearances for product code CAR

  • K920740 — EPISENSOR PLUS (March 7, 1994)
  • K926066 — BION MUMPS-G ANTIBODY TEST SYSTEM (June 15, 1993)

FDA data resources