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)

CARDIOPLEGIA COOLING & ADMIN. SETS

K-Number: K811368 · 1981-06-09

ApplicantBentley Laboratories, Inc.
Decision Date1981-06-09
Product CodeKRI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOPLEGIA COOLING & ADMIN. SETS is the device name listed in this FDA 510(k) record. The listed applicant is Bentley Laboratories, Inc.. It received FDA 510(k) clearance on 1981-06-09 under 510(k) number K811368. The device is classified under product code KRI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIOPLEGIA COOLING & ADMIN. SETS?

CARDIOPLEGIA COOLING & ADMIN. SETS is a medical device that received FDA 510(k) clearance on 1981-06-09. The listed applicant is Bentley Laboratories, Inc.. The 510(k) number is K811368.

When did CARDIOPLEGIA COOLING & ADMIN. SETS receive FDA 510(k) clearance?

CARDIOPLEGIA COOLING & ADMIN. SETS received FDA 510(k) clearance on 1981-06-09, under 510(k) number K811368.

Who is the listed applicant for CARDIOPLEGIA COOLING & ADMIN. SETS?

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

What is the FDA product code for CARDIOPLEGIA COOLING & ADMIN. SETS?

The FDA product code for CARDIOPLEGIA COOLING & ADMIN. SETS is KRI.

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 Bentley Laboratories, 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.

K931967HE-30 GOLDK913956BLOOD CARDIOPLEGIA HEAT EXCHANGER, MODEL #HE-30K913692VENOUS RESERVOIR BAG MODEL NO. BMR-250(TM)K903641QUICK PRIME HEMOCONCEN. NO. HQ-7000 AND CBP-7000QK894826UNIVOX W/HOLDERS, MODELS UNIVOX-HL, HLB, HLFK874867CATR(TM)-H CARDIOTOMY HOLDER

View all 55 devices →

Related Devices (Code: KRI)

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.

K0203653TM MYOCARDIAL NEEDLE-TEMPERATURE PROBE3t Medical Systems, LLCK992635INTERFACE MODULE IDDDStoeckert InstrumenteK990512STOCKERT POWER SUPPLY UNIT FOR S3 COMPONENTSStoeckert InstrumenteK934782AMMEX TUBING ORGANIZERAmmex Cardiopulmonary Corp.K926233CARDIO2 CYCLEErgometrix, Inc.K922404TUBE GRIPGeorgia Medical Products, 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.

↑