FDA 510(k)

HEPARIN COATED LUMINAL PACING CATHETER

K-Number: K875337 · 1988-05-25

Decision Date1988-05-25

Product CodeDQO

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

HEPARIN COATED LUMINAL PACING CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Spectramed, Inc.. It received FDA 510(k) clearance on 1988-05-25 under 510(k) number K875337. 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 HEPARIN COATED LUMINAL PACING CATHETER?

HEPARIN COATED LUMINAL PACING CATHETER is a medical device that received FDA 510(k) clearance on 1988-05-25. The listed applicant is Spectramed, Inc.. The 510(k) number is K875337.

When did HEPARIN COATED LUMINAL PACING CATHETER receive FDA 510(k) clearance?

HEPARIN COATED LUMINAL PACING CATHETER received FDA 510(k) clearance on 1988-05-25, under 510(k) number K875337.

Who is the listed applicant for HEPARIN COATED LUMINAL PACING CATHETER?

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

What is the FDA product code for HEPARIN COATED LUMINAL PACING CATHETER?

The FDA product code for HEPARIN COATED LUMINAL PACING CATHETER 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 Spectramed, Inc. as applicant

K896122AMNICATHDL(TM) DT-IUPC2 DUAL LUMEN TRANS. TIPPED K892941CCO SYSTEM MODEL SP1467,SP5567,SP6267 K895323MODEL DT-BAL, BALANCE SAVER K894362MODEL DT-IUPC2 TRANSDUCER TIPPED DUAL LUMEN IUP K881857AMNICATH(TM) MODEL DT-IUPC TRANS. TIPPED INTRAU.K885235SAFE-DRAW(TM) BLOOD SAMPLING RESERVOIR & ACCESS.

View all 13 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.