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FDA 510(k)

PRESSURE INDICATOR-REGULATOR

K-Number: K813577 · 1982-01-29

ApplicantAdvanced Catheter Systems
Decision Date1982-01-29
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PRESSURE INDICATOR-REGULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Catheter Systems. It received FDA 510(k) clearance on 1982-01-29 under 510(k) number K813577. 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 INDICATOR-REGULATOR?

PRESSURE INDICATOR-REGULATOR is a medical device that received FDA 510(k) clearance on 1982-01-29. The listed applicant is Advanced Catheter Systems. The 510(k) number is K813577.

When did PRESSURE INDICATOR-REGULATOR receive FDA 510(k) clearance?

PRESSURE INDICATOR-REGULATOR received FDA 510(k) clearance on 1982-01-29, under 510(k) number K813577.

Who is the listed applicant for PRESSURE INDICATOR-REGULATOR?

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

What is the FDA product code for PRESSURE INDICATOR-REGULATOR?

The FDA product code for PRESSURE INDICATOR-REGULATOR 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_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 Advanced Catheter Systems 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.

K813624ADVANCED CATHETER SYSTEMS CORONARY GUIDK813623SIMPSON-ROBERT CORONARY GUIDING CATHETK813622INDEFLATORK813578HEMOSTATIC SIDE-ARM ADAPTER

Related Devices (Code: DQO)

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.

K261455Arterial Pressure Monitoring Set/TraySpectrum VascularK252702Bioptimal 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 VascularK250751DualView CatheterTerumo CorporationK242966Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging CatheterGentuity, LLCK242420pNOVUS 21 MicrocatheterPhenox, Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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