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)

ADVANCE PRESSURE MONITOR LINE, HIGH PRES., ADMINI.

K-Number: K897197 · 1990-03-19

ApplicantAdvance Medical Designs, Inc.
Decision Date1990-03-19
Product CodeDTL
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ADVANCE PRESSURE MONITOR LINE, HIGH PRES., ADMINI. is the device name listed in this FDA 510(k) record. The listed applicant is Advance Medical Designs, Inc.. It received FDA 510(k) clearance on 1990-03-19 under 510(k) number K897197. The device is classified under product code DTL. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADVANCE PRESSURE MONITOR LINE, HIGH PRES., ADMINI.?

ADVANCE PRESSURE MONITOR LINE, HIGH PRES., ADMINI. is a medical device that received FDA 510(k) clearance on 1990-03-19. The listed applicant is Advance Medical Designs, Inc.. The 510(k) number is K897197.

When did ADVANCE PRESSURE MONITOR LINE, HIGH PRES., ADMINI. receive FDA 510(k) clearance?

ADVANCE PRESSURE MONITOR LINE, HIGH PRES., ADMINI. received FDA 510(k) clearance on 1990-03-19, under 510(k) number K897197.

Who is the listed applicant for ADVANCE PRESSURE MONITOR LINE, HIGH PRES., ADMINI.?

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

What is the FDA product code for ADVANCE PRESSURE MONITOR LINE, HIGH PRES., ADMINI.?

The FDA product code for ADVANCE PRESSURE MONITOR LINE, HIGH PRES., ADMINI. is DTL.

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 Advance Medical Designs, 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.

K223689Disposable Needle Guides and GridsK163050Advance Medical Designs, Inc. Sterile Ultrasound GelK053495EQUIPMENT SLUSH DRAPEK011265ULTRASOUND TRANSDUCER COVERK012168ADVANCE MEDICAL DESIGNS FLUID POUCHK011422SURGICAL DRAPES

View all 32 devices →

Related Devices (Code: DTL)

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.

K131124COLIGNJilin Coronado Medical , Ltd.K123448AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH BALANCE BIOSURFACE, AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH CARMEDA BIOACTIVEMedtronic, Inc.K122811CONNECTOR COMPONENTS WITH BALANCE BIOSURFACEMedtronic, Inc.K122301GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVEVascular Solutions Zerusa , Ltd.K120069MEDLINE STOPCOCK AND MANIFOLDMedline Industries, Inc.K113148E-PASSSynexmed(Shenzhen)Company Limited

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.

↑