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510(k) K030449

MODIFICATION TO CAPIOX SX10 HARDSHELL RESERVOIR by Terumo Corp. — Product Code DTN

K030449 is an FDA 510(k) premarket notification submitted by Terumo Corp. for the device "MODIFICATION TO CAPIOX SX10 HARDSHELL RESERVOIR". The FDA issued a decision of Substantially Equivalent on March 5, 2003. The device falls under product code DTN (Reservoir, Blood, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4400. Terumo Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 2003
Date Received
February 11, 2003
Clearance Type
Special
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 Terumo Corp.

  • K100282 — TERUMO SURSHIELD- PUR SAFETY I.V. CATHETER (February 26, 2010)
  • K092372 — HEARTRAIL III GUIDING CATHETER (September 11, 2009)
  • K091417 — SINGLE USE GUIDEWIRE, MODELS G-240-2527S, G-240-2545S, G-240-2527A, G-240-2545A, (May 22, 2009)
  • K090973 — TERUMO SURSHIELD SAFETY I.V. CATHETER (18G X 51MM & 20G X 51MM SIZES) (May 1, 2009)
  • K073474 — CAPIOX CIRCUIT CONNECTORS (March 5, 2008)
  • K071572 — CAPIOX FX05 HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER (July 23, 2007)
  • K071494 — CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR AND ARTERIAL FILTER (July 16, 2007)
  • K071075 — TERUMO DIGITAL BLOOD PRESSURE MONITOR ES-H55A (May 25, 2007)
  • K040783 — FOUNDATION (October 13, 2004)
  • K040210 — CAPIOX RX25 HOLLOW FIBER OXYGENATOR W/WO HARDSHELL RESERVOIR (March 3, 2004)

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