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510(k) K912773

UNIPOLAR UPSIZING ADAPTOR by Telectronics Pacing Systems, Inc. — Product Code DTD

K912773 is an FDA 510(k) premarket notification submitted by Telectronics Pacing Systems, Inc. for the device "UNIPOLAR UPSIZING ADAPTOR". The FDA issued a decision of Substantially Equivalent on October 23, 1991. The device falls under product code DTD (Pacemaker Lead Adaptor), a Class II device regulated under 21 CFR 870.3620. Telectronics Pacing Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 1991
Date Received
June 24, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pacemaker Lead Adaptor
Device Class
Class II
Regulation Number
870.3620
Review Panel
CV
Submission Type

Other clearances by Telectronics Pacing Systems, Inc.

  • K961118 — MAXIM PF MODELS 033-581/033-590 (July 15, 1996)
  • K943657 — STERILIZATION (June 24, 1996)
  • K934899 — BIFURCATED LEAD ADAPTORS, 3.2MM & 5.0 MM (May 12, 1994)
  • K926340 — NEW LEAD INTRODUCER KITS, VARIOUS MODELS (May 27, 1993)
  • K914489 — NEW EXTRUSION VENDOR FOR POLYURETHANE TUBING (August 17, 1992)
  • K913919 — UNIVERSAL TERMINAL CAP, 3.2MM (December 31, 1991)
  • K911273 — 100 CM PERMANENT PACING LEAD MODELS (August 28, 1991)
  • K910112 — BIFURCATED VS-1 TO VS-1 LEAD ADAPTOR (February 25, 1991)
  • K903186 — OPTIMA SERIES II MODEL 147B SINGLE CHAMBER PULSE (January 18, 1991)
  • K904741 — LASERDISH POLY UNIPOLAR VENTRI LEAD W/TRAIL TINES (January 8, 1991)

Other clearances for product code DTD

  • K143463 — IS4/DF4 Port Plug (March 19, 2015)
  • K132008 — 6981M LEAD EXTENDER KIT, 6984M LEAD EXTENDER KIT, 6986M LEAD EXTENDER KIT, 5866- (July 30, 2013)
  • K041574 — CPI LEAD ADAPTERS, MODELS 6017, 6018 AND 6020 (July 12, 2004)
  • K031164 — PACING LEAD ADAPTORS, BIPOLAR, MODELS ILINK-BIS, ILINK-BLV (June 19, 2003)
  • K024156 — PACING LEAD EXTENSIONS, BIPOLAR, PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR,PACING L (January 14, 2003)
  • K010787 — PACING LEAD BIPOLAR ADAPTERS AND EXTENSIONS (May 22, 2001)
  • K003454 — A1-CS-SB Y-ADAPTER, MODEL 124 871 (January 18, 2001)
  • K000210 — MODIFICATION TO MODEL 5866-37M LEAD ADAPTOR KIT (February 23, 2000)
  • K982220 — MODEL 2872 BIPOLAR LEAD ADAPTOR KIT (October 15, 1998)
  • K971930 — BK-N SEALING CAP (August 14, 1997)

FDA data resources