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)

PASSPORT 5L-CE MODEL 0998-00-0131XXX

K-Number: K974178 · 1998-06-26

ApplicantDatascope Corp.
Decision Date1998-06-26
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PASSPORT 5L-CE MODEL 0998-00-0131XXX is the device name listed in this FDA 510(k) record. The listed applicant is Datascope Corp.. It received FDA 510(k) clearance on 1998-06-26 under 510(k) number K974178. The device is classified under product code DRT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PASSPORT 5L-CE MODEL 0998-00-0131XXX?

PASSPORT 5L-CE MODEL 0998-00-0131XXX is a medical device that received FDA 510(k) clearance on 1998-06-26. The listed applicant is Datascope Corp.. The 510(k) number is K974178.

When did PASSPORT 5L-CE MODEL 0998-00-0131XXX receive FDA 510(k) clearance?

PASSPORT 5L-CE MODEL 0998-00-0131XXX received FDA 510(k) clearance on 1998-06-26, under 510(k) number K974178.

Who is the listed applicant for PASSPORT 5L-CE MODEL 0998-00-0131XXX?

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

What is the FDA product code for PASSPORT 5L-CE MODEL 0998-00-0131XXX?

The FDA product code for PASSPORT 5L-CE MODEL 0998-00-0131XXX is DRT.

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 Datascope Corp. 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.

K190884TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery ToolK181122CARDIOSAVE Intra-Aortic Balloon PumpK172305CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon PumpK163542CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage CaseK133074MEGA 8FR. 50CC AND SENSATION PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETERS AND ACCESSORIESK071805NETGUARD AUTOMATED CLINICIAN ALERT SYSTEM, MODEL 0998-00-1600-XX

View all 135 devices →

Related Devices (Code: DRT)

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.

K254058DistaSense(TM) (v1)Life Detection TechnologiesK261286The Circadia C300 System (C300)Circadia Health, Inc.K252676The Circadia C300 System (C300)Circadia Health, Inc.K253388Sleepiz One+ (Model 2.5)Sleepiz AGK251364Sleepiz One+ (2.5)Sleepiz AGK234003The Circadia C200 SystemCircadia Technologies, Ltd.

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.

↑