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)

TEMP. PACING LEAD, BIPOLAR #TH60, 90/110

K-Number: K830772 · 1983-04-18

ApplicantOscor, Inc.
Decision Date1983-04-18
Product CodeLDF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TEMP. PACING LEAD, BIPOLAR #TH60, 90/110 is the device name listed in this FDA 510(k) record. The listed applicant is Oscor, Inc.. It received FDA 510(k) clearance on 1983-04-18 under 510(k) number K830772. The device is classified under product code LDF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TEMP. PACING LEAD, BIPOLAR #TH60, 90/110?

TEMP. PACING LEAD, BIPOLAR #TH60, 90/110 is a medical device that received FDA 510(k) clearance on 1983-04-18. The listed applicant is Oscor, Inc.. The 510(k) number is K830772.

When did TEMP. PACING LEAD, BIPOLAR #TH60, 90/110 receive FDA 510(k) clearance?

TEMP. PACING LEAD, BIPOLAR #TH60, 90/110 received FDA 510(k) clearance on 1983-04-18, under 510(k) number K830772.

Who is the listed applicant for TEMP. PACING LEAD, BIPOLAR #TH60, 90/110?

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

What is the FDA product code for TEMP. PACING LEAD, BIPOLAR #TH60, 90/110?

The FDA product code for TEMP. PACING LEAD, BIPOLAR #TH60, 90/110 is LDF.

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 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.

K210627Breezeway IIK130104GUIDEWIRE, PURSUER SERIESK122958DELIVERY SHEATH, MODEL ADELANTE BREEZEWAYK122960STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINOK122084INTRODUCER SET, MODEL ADELANTE-S SERIESK120459STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO

View all 43 devices →

Related Devices (Code: LDF)

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.

K252042Sync AV II Temporary Pacing CatheterSwift Sync, Inc.K242863Bioptimal Bipolar Pacing CatheterBioptimal International Pte. , Ltd.K251186Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)C.R. Bard, Inc.K241334Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 5Fr. (006225P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 6Fr. (006241P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 7Fr. (006242P); NBIH™ Temporary Pacing Electrode Catheter,C.R. Bard, Inc.K241199Rotatable Connector (5944RL)Shenzhen Launch Electrical Co., Ltd.K242705Streamline Unipolar Pediatric Temporary Pacing Lead (6491) Streamline Unipolar Temporary Atrial Pacing Lead (6492) Streamline Unipolar Temporary Myocardial Pacing Wire (6494) Streamline Bipolar Temporary Myocardial Pacing Lead (6495) Streamline Unipolar Temporary Myocardial Pacing Lead (6500)Medtronic, 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.

↑