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510(k) K940467

REMINGTON MEDICAL DISPOSABLE EXTENSION CABLE FAS-LOC FL-601 by Remington Medical, Inc. — Product Code DTE

K940467 is an FDA 510(k) premarket notification submitted by Remington Medical, Inc. for the device "REMINGTON MEDICAL DISPOSABLE EXTENSION CABLE FAS-LOC FL-601". The FDA issued a decision of Substantially Equivalent on November 1, 1994. The device falls under product code DTE (Pulse-Generator, Pacemaker, External), a Class II device regulated under 21 CFR 870.3600. Remington Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 1994
Date Received
February 2, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pulse-Generator, Pacemaker, External
Device Class
Class II
Regulation Number
870.3600
Review Panel
CV
Submission Type

Other clearances by Remington Medical, Inc.

  • K251904 — VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speake (November 20, 2025)
  • K241583 — VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charge (August 30, 2024)
  • K211589 — VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charge (January 27, 2022)
  • K212065 — VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charge (October 7, 2021)
  • K191315 — Remington Medical, Inc. Automatic Cutting Needle (NAC) (July 12, 2019)
  • K150266 — Remington Medical Inc. Tuohy Epidural Needles (June 4, 2015)
  • K130282 — REMINGTON MEDICAL CENTREFIRE 22 BIOPSY INSTRUMENT (May 13, 2013)
  • K050884 — ADAPTER CABLE (May 19, 2005)
  • K040266 — CORE NEEDLE BIOPSY (July 9, 2004)
  • K990428 — DRAINAGE BAG (August 12, 1999)

Other clearances for product code DTE

  • K241781 — Solo Pace Control (January 10, 2025)
  • K232721 — Lifetech Cardio Temporary Pacemaker (January 7, 2024)
  • K201011 — Medtronic Model 5392 External Pulse Generator (EPG) (May 13, 2020)
  • K190825 — Medtronic Model 5392 External Pulse Generator (EPG) (April 30, 2019)
  • K182839 — Lifetech Cardio Model 8301 Temporary Pacemaker (February 28, 2019)
  • K181973 — Medtronic Model 5392 External Pulse Generator (EPG) (August 21, 2018)
  • K180873 — Medtronic Model 53401 External Pulse Generator (EPG) (April 19, 2018)
  • K162054 — Medtronic Temporary External Pacemaker 53401 (October 18, 2016)
  • K162550 — Medtronic Model 5392 External Pulse Generator (EPG) (October 12, 2016)
  • K150246 — Medtronic Model 5392 External Pulse Generator (EPG) (February 18, 2015)

FDA data resources