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510(k) K831926

IMPLANTABLE ENDOCARDIAL PACING LEADS by Oscor, Inc. — Product Code DTG

K831926 is an FDA 510(k) premarket notification submitted by Oscor, Inc. for the device "IMPLANTABLE ENDOCARDIAL PACING LEADS". The FDA issued a decision of Substantially Equivalent on March 12, 1984. The device falls under product code DTG (Magnet, Test, Pacemaker), a Class I device regulated under 21 CFR 870.3690. Oscor, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 1984
Date Received
June 15, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Magnet, Test, Pacemaker
Device Class
Class I
Regulation Number
870.3690
Review Panel
CV
Submission Type

Other clearances by Oscor, Inc.

  • K210627 — Breezeway II (June 3, 2021)
  • K151951 — Destino Reach (September 22, 2015)
  • K143463 — IS4/DF4 Port Plug (March 19, 2015)
  • K140917 — INTRODUCER, MODEL ADELANTE MAGNUM (July 9, 2014)
  • K140406 — DESTINO TWIST, STEERABLE GUIDING SHEATH (April 17, 2014)
  • K130633 — INTRODUCER SETS, MODEL ADELANTE RADIAL (February 13, 2014)
  • K130843 — SAFESEPT NEEDLE FREE TRANSSEPTAL TROCAR GUIDEWIRE (January 8, 2014)
  • K130104 — GUIDEWIRE, PURSUER SERIES (June 13, 2013)
  • K122960 — STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO (December 13, 2012)
  • K122958 — DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY (December 13, 2012)

Other clearances for product code DTG

  • K092364 — MODEL 220 PATIENT MAGNET (November 3, 2009)
  • K960849 — MAGNO ALARM (March 26, 1997)
  • K895110 — MAESTRO PACEMAKER TEST MAGNET (September 26, 1989)
  • K813153 — TEST MAGNET (December 2, 1981)

FDA data resources