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510(k) K123916

PSA SERIES by Osypka Medical, Inc. — Product Code DTE

K123916 is an FDA 510(k) premarket notification submitted by Osypka Medical, Inc. for the device "PSA SERIES". The FDA issued a decision of Substantially Equivalent (kit) on April 9, 2013. The device falls under product code DTE (Pulse-Generator, Pacemaker, External), a Class II device regulated under 21 CFR 870.3600. Osypka Medical, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
April 9, 2013
Date Received
December 19, 2012
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 Osypka Medical, Inc.

  • K082242 — ICON, MODEL C3 (October 8, 2008)
  • K081035 — AESCULON C2, AESCULON CHF CLINIC C2, AESCULON HYPERTENSION CLINIC C2 AND AESCULO (May 30, 2008)
  • K070985 — AESCULON CHF, HYPERTENSION & PACEMAKER CLINIC (February 1, 2008)
  • K033130 — PACE 101/PACE 101H, MODEL 3077 SSI TEMPORARY PULSE GENERATOR (October 31, 2003)
  • K022939 — OSCOR PACE 101/101H AND ACCESSORIES, ST.JUDE MEDICAL MODEL 3077 AND ACCESSORIES, (October 3, 2002)
  • K020896 — OSCOR PACE 203/PACE 203H DUAL-CHAMBER TEMPORARY PACEMAKER, ST. JUDE MEDICAL, MOD (June 14, 2002)

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