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510(k) K950140

IS-1/QUADRIPOLAR TERMINAL CAP, PART NUMBER 6011069 by Pacesetter, Inc. — Product Code DTD

K950140 is an FDA 510(k) premarket notification submitted by Pacesetter, Inc. for the device "IS-1/QUADRIPOLAR TERMINAL CAP, PART NUMBER 6011069". The FDA issued a decision of Substantially Equivalent on April 6, 1995. The device falls under product code DTD (Pacemaker Lead Adaptor), a Class II device regulated under 21 CFR 870.3620. Pacesetter, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 6, 1995
Date Received
January 13, 1995
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 Pacesetter, Inc.

  • K972814 — LOCATOR MODEL 4036 (February 23, 1998)
  • K960854 — SIEMENS SERVO ULTRA NEBULIZER 345 (December 23, 1996)
  • K954714 — AFP CARDIAC PACING SYSTEM MODEL 283 (MODIFICATION) (February 1, 1996)
  • K954551 — DF-1 TERMINAL CAP (December 26, 1995)
  • K952206 — PASSIVE PLUS PACING LEADS WITH TITANIUM NITRIDE COATING (August 31, 1995)
  • K951950 — PASSIVE PLUS PACING LEADS WITH TITANIUM NITRIDE COATING (August 31, 1995)
  • K951087 — TENDRIL, UNIPOLAR ENDOCARDIAL SCREW-IN LEAD (June 29, 1995)

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