Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SLIM VENT UNIPO PACING LEAD USING POLYU 90A,30-281

K-Number: K852915 · 1985-07-29

ApplicantTelectronics, Inc.
Decision Date1985-07-29
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SLIM VENT UNIPO PACING LEAD USING POLYU 90A,30-281 is the device name listed in this FDA 510(k) record. The listed applicant is Telectronics, Inc.. It received FDA 510(k) clearance on 1985-07-29 under 510(k) number K852915. The device is classified under product code DTB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SLIM VENT UNIPO PACING LEAD USING POLYU 90A,30-281?

SLIM VENT UNIPO PACING LEAD USING POLYU 90A,30-281 is a medical device that received FDA 510(k) clearance on 1985-07-29. The listed applicant is Telectronics, Inc.. The 510(k) number is K852915.

When did SLIM VENT UNIPO PACING LEAD USING POLYU 90A,30-281 receive FDA 510(k) clearance?

SLIM VENT UNIPO PACING LEAD USING POLYU 90A,30-281 received FDA 510(k) clearance on 1985-07-29, under 510(k) number K852915.

Who is the listed applicant for SLIM VENT UNIPO PACING LEAD USING POLYU 90A,30-281?

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

What is the FDA product code for SLIM VENT UNIPO PACING LEAD USING POLYU 90A,30-281?

The FDA product code for SLIM VENT UNIPO PACING LEAD USING POLYU 90A,30-281 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 Telectronics, 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.

K890895IMPLANTABLE ADAPTOR 033-380K891231OPTIMA MPT AND SPT PACEMAKERSK890350VS-1 SILICONE IMPLANT LEADS (NEW SERIAL # TUBE)K884411OPTIMA MPT AND SPT PACEMAKERSK884278IMPLANTABLE ELECTRODE LEADS 033-400,402 AND 436K881837OPTIMA MPT SERIES III PACEMAKER, 5281D AND 5282D

View all 107 devices →

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.

↑