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510(k) K970347

MPC (MODEL 7000) EXTERNAL TEMPORARY PACEMAKER SYSTEM by Paladin Medical, Inc. — Product Code DTE

K970347 is an FDA 510(k) premarket notification submitted by Paladin Medical, Inc. for the device "MPC (MODEL 7000) EXTERNAL TEMPORARY PACEMAKER SYSTEM". The FDA issued a decision of Substantially Equivalent on August 29, 1997. The device falls under product code DTE (Pulse-Generator, Pacemaker, External), a Class II device regulated under 21 CFR 870.3600. Paladin Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 1997
Date Received
January 27, 1997
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 Paladin Medical, Inc.

  • K993306 — NIKOPAD ELECTROSURGICAL GROUNDING PAD (*OR SOLD UNDER COMMERCIAL NAMES), MODEL 4 (November 3, 1999)
  • K971290 — STRATASYS FDM MEDMODELER SYSTEM (June 20, 1997)
  • K964222 — ACU-CLENS CLEANING SYSTEM FOR CONTACT LENS CLEANING (December 20, 1996)
  • K950054 — ENDO-BEND(TM) SHAVER (June 29, 1995)
  • K935220 — CORE PREVENT MATTRESS MODIFICATION (November 29, 1993)
  • K921015 — SHARPE ENDOSPONGE ASPIIRATOR (May 21, 1993)
  • K915743 — SHARPE ENDOTENACULUM (May 20, 1993)
  • K921888 — SHARPE ENDODISSECTOR (October 20, 1992)
  • K915749 — SHARPE ENDOLIGATURE CARRIER (October 20, 1992)
  • K915744 — SHARPE ENDOHEMOSTAT (October 20, 1992)

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