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510(k) K982136

JOSTRA VENOUS HARDSHELL CARDIOTOMIC RESERVOIR VHK 4200 by Schiff & Co. — Product Code DTN

K982136 is an FDA 510(k) premarket notification submitted by Schiff & Co. for the device "JOSTRA VENOUS HARDSHELL CARDIOTOMIC RESERVOIR VHK 4200". The FDA issued a decision of Substantially Equivalent on March 24, 1999. The device falls under product code DTN (Reservoir, Blood, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4400. Schiff & Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 1999
Date Received
June 17, 1998
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 Schiff & Co.

  • K990511 — X-TIP INTRAOSSEOUS PERFORATOR (April 27, 1999)
  • K981629 — NUTRISAFE ENTERAL FEEDING TUBE (February 4, 1999)
  • K981630 — VYGON DOUBLE LUMEN UMBILICAL CATHETER (October 1, 1998)
  • K974141 — PLUS REUSABLE RESUSCITATOR (May 21, 1998)
  • K954448 — VIOTEC V-2200 ULTRAVIOLET GERMICIDAL AIR PURIFICATION SYSTEM (October 28, 1996)
  • K955085 — HM-CAP EIA TEST (MODIFICATION) (February 9, 1996)
  • K944159 — HM-CAP EIA KIT (July 18, 1995)
  • K943521 — VIOTEC 1400 SERIES ULTRAVIOLET GERMICIDAL FIXTURE (February 14, 1995)
  • K896684 — KEMBLE LIQUID HANDLING SYSTEM DISPENSER (April 16, 1990)
  • K894617 — OLYMPUS PK-TP SYSTEM REACTIVE CONTROL (October 31, 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