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FDA 510(k)

SILICONE BIPOLAR LEAD MODELS 1136T, 1142T &1146T

K-Number: K930876 · 1994-06-15

ApplicantSiemens-Pacesetter, Inc.
Decision Date1994-06-15
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

SILICONE BIPOLAR LEAD MODELS 1136T, 1142T &1146T is the device name listed in this FDA 510(k) record. The listed applicant is Siemens-Pacesetter, Inc.. It received FDA 510(k) clearance on 1994-06-15 under 510(k) number K930876. The device is classified under product code DTB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent - Subject to Tracking Reg..

Frequently Asked Questions

What is the SILICONE BIPOLAR LEAD MODELS 1136T, 1142T &1146T?

SILICONE BIPOLAR LEAD MODELS 1136T, 1142T &1146T is a medical device that received FDA 510(k) clearance on 1994-06-15. The listed applicant is Siemens-Pacesetter, Inc.. The 510(k) number is K930876.

When did SILICONE BIPOLAR LEAD MODELS 1136T, 1142T &1146T receive FDA 510(k) clearance?

SILICONE BIPOLAR LEAD MODELS 1136T, 1142T &1146T received FDA 510(k) clearance on 1994-06-15, under 510(k) number K930876.

Who is the listed applicant for SILICONE BIPOLAR LEAD MODELS 1136T, 1142T &1146T?

The FDA 510(k) record lists Siemens-Pacesetter, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SILICONE BIPOLAR LEAD MODELS 1136T, 1142T &1146T?

The FDA product code for SILICONE BIPOLAR LEAD MODELS 1136T, 1142T &1146T is DTB.

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Other records listing Siemens-Pacesetter, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K942440AFP CARDIAC PACING SYSTEM MODEL 283K925038PACING LEAD MODEL 1188TK932892PASSIVE PLUS ENDOCARDIAL PACING LEADS VAR. MODELSK925347MODEL 1148T TRANSVENOUS, SCREW-IN LEADK920822CARDIOVASCULAR PERMANENT PACEMAKER ELECTRODEK921318ADAPTING SLEEVE KIT MODEL 4023

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Related Devices (Code: DTB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K061212BIOTRONIK ENDOCARDIAL PACING LEADSBiotronik, Inc.K041809PERMANENT PACING LEAD, MODEL PY2Oscor, Inc.K040569PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJUOscor, Inc.K031274MODEL 5071 MYOCARDIAL PACING LEADMedtronic VascularK031210MODEL 4951M MYOCARDIAL UNIPOLAR LEADMetronic, Inc.K023205ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BPBiotronik, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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