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510(k) K890077

TRAUMAFUSE RAPID INFUSION DEVICE by The Traumafuse Co. — Product Code DTN

K890077 is an FDA 510(k) premarket notification submitted by The Traumafuse Co. for the device "TRAUMAFUSE RAPID INFUSION DEVICE". The FDA issued a decision of Substantially Equivalent on April 3, 1989. The device falls under product code DTN (Reservoir, Blood, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4400. The Traumafuse Co. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 1989
Date Received
January 9, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reservoir, Blood, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4400
Review Panel
CV
Submission Type

Other clearances by The Traumafuse Co.

  • K895162 — TRAUMAFUSE TRACH SHIELD (January 9, 1990)
  • K894721 — TRAUMAFUSE PERFUSION PRESSURE RELIEF VALVE (October 20, 1989)
  • K895132 — CONNELL-STEPHENS ENDO ANESS TUBE (October 13, 1989)

Other clearances for product code DTN

  • K251783 — Inspire HCR and HCR DUAL cardiotomy reservoirs (December 22, 2025)
  • K241206 — Quantum Perfusion Hybrid System (July 18, 2024)
  • K241053 — MVR™ Venous Reservoir Bag 800 mL; MVR™ Venous Reservoir Bag 1600 mL; MVR™ Venous (May 15, 2024)
  • K223361 — BMR 1900 PHISIO (June 10, 2023)
  • K170583 — Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface (March 17, 2017)
  • K161733 — INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C (March 8, 2017)
  • K153143 — Capiox Advance Hardshell Reservoir (December 2, 2015)
  • K151110 — Intersept Filtered Cardiotomy Reservoir (May 27, 2015)
  • K141432 — NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVIOR, PEDIATRIC VENOUS HARDSHELL CARDI (July 7, 2014)
  • K141233 — AFFINITY PIXIE OXYGENATION SYSTEM WITH; CARMEDA BIOACTIVE SURFACE, BALANCE BIOSU (June 12, 2014)

FDA data resources