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510(k) K002496

MODEL 4815 ADAPTER by Pace Medical — Product Code DTN

K002496 is an FDA 510(k) premarket notification submitted by Pace Medical for the device "MODEL 4815 ADAPTER". The FDA issued a decision of Substantially Equivalent on October 10, 2000. The device falls under product code DTN (Reservoir, Blood, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4400. Pace Medical has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 2000
Date Received
August 14, 2000
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 Pace Medical

  • K011980 — ADAPTER, PACING ANALYZER/UNIVERSAL PACING ADAPTER, MODELS 4820 AND 4825 (September 12, 2001)
  • K012392 — DISPOSABLE SURGICAL EXTENSION CABLE, MODEL 4255 AND MODEL 4260 (September 4, 2001)
  • K002204 — PACEMAKER EXTENSION CABLE MODELS 4265,4265A, 4265V, 5265, 5265A, 5265V (October 18, 2000)
  • K002497 — MODEL 4810 ANALYZER OUTPUT ADAPTER (October 10, 2000)
  • K001180 — TEMPORARY PACEMAKER EXTENSION CABLE, MODELS 5235, 5235A, 5235V, TEMPORARY PACEMA (June 27, 2000)
  • K925143 — MODEL 4800 ACCUPACE PACING SYSTEM ANALYER (September 27, 1994)
  • K931662 — LEAD INTRODUCER SET, VARIOUS MODELS AND SIZES (August 31, 1993)
  • K922899 — MODEL 4280 SURGICAL EXTENSION CABLE (December 23, 1992)
  • K913805 — MINIATURE MODELS 4562/4563/4572/4573 PACEMAKER (November 19, 1991)
  • K913134 — MODEL 4220 (August 22, 1991)

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