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FDA 510(k)

PACING LEAD MODEL 1188T

K-Number: K925038 · 1994-07-15

ApplicantSiemens-Pacesetter, Inc.
Decision Date1994-07-15
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

PACING LEAD MODEL 1188T 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 1994-07-15 under 510(k) number K925038. 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 PACING LEAD MODEL 1188T?

PACING LEAD MODEL 1188T is a medical device that received FDA 510(k) clearance on 1994-07-15. The listed applicant is Siemens-Pacesetter, Inc.. The 510(k) number is K925038.

When did PACING LEAD MODEL 1188T receive FDA 510(k) clearance?

PACING LEAD MODEL 1188T received FDA 510(k) clearance on 1994-07-15, under 510(k) number K925038.

Who is the listed applicant for PACING LEAD MODEL 1188T?

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 PACING LEAD MODEL 1188T?

The FDA product code for PACING LEAD MODEL 1188T 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 283K932892PASSIVE PLUS ENDOCARDIAL PACING LEADS VAR. MODELSK930876SILICONE BIPOLAR LEAD MODELS 1136T, 1142T &1146TK925347MODEL 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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