Home / 510(k) Clearances / K893705

510(k) K893705

SAFE-1 VENOUS RESERVOIR by Polystan C/O Vitalcor, Inc. — Product Code DTN

K893705 is an FDA 510(k) premarket notification submitted by Polystan C/O Vitalcor, Inc. for the device "SAFE-1 VENOUS RESERVOIR". The FDA issued a decision of Substantially Equivalent on December 22, 1989. The device falls under product code DTN (Reservoir, Blood, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4400. Polystan C/O Vitalcor, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1989
Date Received
May 18, 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 Polystan C/O Vitalcor, Inc.

  • K894657 — POLYSTAN HEART-LUNG MACHINE SYSTEM (March 28, 1990)
  • K893940 — POLYSTAN HEATER-COOLER UNIT (January 18, 1990)
  • K893704 — SAFE-1 (December 22, 1989)
  • K874853 — POLYSTAN TWO STAGE CATHETERS (February 5, 1988)
  • K874852 — POLYSTAN WIRE REINFORCED TWO STAGE CATHETERS (February 5, 1988)
  • K872182 — POLYSTAN WIRE REINFORCED CATHETERS AND CANNULAE (October 30, 1987)
  • K843538 — PO 2 LYTRODE (October 18, 1984)

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