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FDA 510(k)

PROCEDURE PACKS PRESS. MONITOR/ADMINISTRATION LINE

K-Number: K882655 · 1988-09-16

ApplicantProcedure Packs, Inc.
Decision Date1988-09-16
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PROCEDURE PACKS PRESS. MONITOR/ADMINISTRATION LINE is the device name listed in this FDA 510(k) record. The listed applicant is Procedure Packs, Inc.. It received FDA 510(k) clearance on 1988-09-16 under 510(k) number K882655. 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 PROCEDURE PACKS PRESS. MONITOR/ADMINISTRATION LINE?

PROCEDURE PACKS PRESS. MONITOR/ADMINISTRATION LINE is a medical device that received FDA 510(k) clearance on 1988-09-16. The listed applicant is Procedure Packs, Inc.. The 510(k) number is K882655.

When did PROCEDURE PACKS PRESS. MONITOR/ADMINISTRATION LINE receive FDA 510(k) clearance?

PROCEDURE PACKS PRESS. MONITOR/ADMINISTRATION LINE received FDA 510(k) clearance on 1988-09-16, under 510(k) number K882655.

Who is the listed applicant for PROCEDURE PACKS PRESS. MONITOR/ADMINISTRATION LINE?

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

What is the FDA product code for PROCEDURE PACKS PRESS. MONITOR/ADMINISTRATION LINE?

The FDA product code for PROCEDURE PACKS PRESS. MONITOR/ADMINISTRATION LINE 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 Procedure Packs, 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.

K891572ANGIOGRAPHY CUSTOM PACKSK882717PROCEDURE PACKS CONTRAST MEDIA SETSK882716PROCEDURE PACKS SOLUTION ADMINISTRATION SETS

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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