FDA 510(k)

PRESSURE MONITORING INJECTION LINES

K-Number: K781558 · 1978-10-10

Decision Date1978-10-10

Product CodeDQO

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

PRESSURE MONITORING INJECTION LINES is the device name listed in this FDA 510(k) record. The listed applicant is Cobe Laboratories, Inc.. It received FDA 510(k) clearance on 1978-10-10 under 510(k) number K781558. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRESSURE MONITORING INJECTION LINES?

PRESSURE MONITORING INJECTION LINES is a medical device that received FDA 510(k) clearance on 1978-10-10. The listed applicant is Cobe Laboratories, Inc.. The 510(k) number is K781558.

When did PRESSURE MONITORING INJECTION LINES receive FDA 510(k) clearance?

PRESSURE MONITORING INJECTION LINES received FDA 510(k) clearance on 1978-10-10, under 510(k) number K781558.

Who is the listed applicant for PRESSURE MONITORING INJECTION LINES?

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

What is the FDA product code for PRESSURE MONITORING INJECTION LINES?

The FDA product code for PRESSURE MONITORING INJECTION LINES is DQO.

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Cobe Laboratories, Inc. as applicant

K923272COBE CMS-HF HOLLOW FIBER MEMBRANE OXYGENATOR K900105COBE SPECTRA BLOOD COMPONENT SEPARATOR THERAPEUTIC K905793COBE CENTRY 2 BICART OPTION KIT K905388COBE CENTRYSYSTEM 3 BICART OPTION KIT K904336NEW COBE SATURATION/HEMATOCRIT MONITOR K902631COBE ICU CONVERSION KIT

View all 77 devices →

Related Devices (Code: DQO)

K261455Arterial Pressure Monitoring Set/TraySpectrum Vascular K252702Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-110NDCF, TD2502-110NCGF, TD2502-110NDCGF, TD2502-110NXF, TD2502-110NXGF, TD2502-110NDXF, TD2502-110NXCF, TD2502-110NDXGF, TD2502-110NDXCF ,TD2502-110NXCGF, TD2502-110NDXCGF, TD2602NF, TD2602NBioptimal International Pte. , Ltd.K254278Arterial Pressure Monitoring Set/TraySpectrum Vascular K250751DualView CatheterTerumo Corporation K242966Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging CatheterGentuity, LLC K242420pNOVUS 21 MicrocatheterPhenox, 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.