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)

CARDIAC PROBE

K-Number: K760595 · 1976-09-17

ApplicantG.D. Searle and Co.
Decision Date1976-09-17
Product CodeIZD
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CARDIAC PROBE is the device name listed in this FDA 510(k) record. The listed applicant is G.D. Searle and Co.. It received FDA 510(k) clearance on 1976-09-17 under 510(k) number K760595. The device is classified under product code IZD. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIAC PROBE?

CARDIAC PROBE is a medical device that received FDA 510(k) clearance on 1976-09-17. The listed applicant is G.D. Searle and Co.. The 510(k) number is K760595.

When did CARDIAC PROBE receive FDA 510(k) clearance?

CARDIAC PROBE received FDA 510(k) clearance on 1976-09-17, under 510(k) number K760595.

Who is the listed applicant for CARDIAC PROBE?

The FDA 510(k) record lists G.D. Searle and Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARDIAC PROBE?

The FDA product code for CARDIAC PROBE is IZD.

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 G.D. Searle and Co. 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.

K821159IN-LINE OXYGEN MONITORING SYSTEMK811068BYPASS COILK811071VENOUS OXYGEN PROBEK803238INTRAVASCULAR CATHETERK810630SILICONE ELASTOMER COATED LATEX FOLEYK810131ADMINISTRATION SET

View all 56 devices →

Related Devices (Code: IZD)

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.

K123917DECLIPSESPECT VIEWERSurgiceye GmbHK101887CONFIDENT SURGERY SUITE 300, MODEL CSS300Surgiceye GmbHK013751HANDHELD GAMMA FINDER (HGF)Silicon Instruments GmhbK983768MODIFICATION TO GAMMA GUIDANCE SYSTEMRadiation Monitoring Devices, Inc.K982442C-TRAK AUTOMATIC ANALYZER (NAME CHANGE FROM ONCOPROBE II TO C-TRAK)Care Wise Medical Products Corp.K971167NEOPROBE MODEL 1500 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIESNeoprobe Corp.

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.

↑