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FDA 510(k)

HT, MODEL HT PB

K-Number: K990142 · 1999-07-30

ApplicantSulzer Oscor, Inc.
Decision Date1999-07-30
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

HT, MODEL HT PB is the device name listed in this FDA 510(k) record. The listed applicant is Sulzer Oscor, Inc.. It received FDA 510(k) clearance on 1999-07-30 under 510(k) number K990142. 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 HT, MODEL HT PB?

HT, MODEL HT PB is a medical device that received FDA 510(k) clearance on 1999-07-30. The listed applicant is Sulzer Oscor, Inc.. The 510(k) number is K990142.

When did HT, MODEL HT PB receive FDA 510(k) clearance?

HT, MODEL HT PB received FDA 510(k) clearance on 1999-07-30, under 510(k) number K990142.

Who is the listed applicant for HT, MODEL HT PB?

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

What is the FDA product code for HT, MODEL HT PB?

The FDA product code for HT, MODEL HT PB is DTB.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Sulzer Oscor, 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.

K970497PACE 101H

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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