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510(k) K925347

MODEL 1148T TRANSVENOUS, SCREW-IN LEAD by Siemens-Pacesetter, Inc. — Product Code DTB

K925347 is an FDA 510(k) premarket notification submitted by Siemens-Pacesetter, Inc. for the device "MODEL 1148T TRANSVENOUS, SCREW-IN LEAD". The FDA issued a decision of Substantially Equivalent on June 10, 1993. The device falls under product code DTB (Permanent Pacemaker Electrode), a Class III device regulated under 21 CFR 870.3680. Siemens-Pacesetter, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 1993
Date Received
October 22, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Permanent Pacemaker Electrode
Device Class
Class III
Regulation Number
870.3680
Review Panel
CV
Submission Type

Other clearances by Siemens-Pacesetter, Inc.

  • K942440 — AFP CARDIAC PACING SYSTEM MODEL 283 (August 8, 1994)
  • K925038 — PACING LEAD MODEL 1188T (July 15, 1994)
  • K932892 — PASSIVE PLUS ENDOCARDIAL PACING LEADS VAR. MODELS (July 6, 1994)
  • K930876 — SILICONE BIPOLAR LEAD MODELS 1136T, 1142T &1146T (June 15, 1994)
  • K920822 — CARDIOVASCULAR PERMANENT PACEMAKER ELECTRODE (January 22, 1993)
  • K921318 — ADAPTING SLEEVE KIT MODEL 4023 (August 3, 1992)

Other clearances for product code DTB

  • K061212 — BIOTRONIK ENDOCARDIAL PACING LEADS (July 10, 2006)
  • K041809 — PERMANENT PACING LEAD, MODEL PY2 (August 6, 2004)
  • K040569 — PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJU (April 7, 2004)
  • K031274 — MODEL 5071 MYOCARDIAL PACING LEAD (May 22, 2003)
  • K031210 — MODEL 4951M MYOCARDIAL UNIPOLAR LEAD (May 16, 2003)
  • K023205 — ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BP (April 24, 2003)
  • K024053 — PERMANENT PACING LEADS, MODELS PHYSIQUE PB AND PJB (January 31, 2003)
  • K023803 — MODIFICATION TO BIOTRONIK'S STERILIZATION PROCESS (December 11, 2002)
  • K023099 — AROX 45-JBP; AROX 53-JBP; MEROX 45-JBP; MEROX 53-JBP (October 18, 2002)
  • K021217 — AROX 53-BP; AROX 60-BP; AROX 45-JBP; AROX 53-JBP (May 1, 2002)

FDA data resources