FDA 510(k)

SONICATH(TM) 5 F

K-Number: K895542 · 1990-04-06

Decision Date1990-04-06

Product CodeDQO

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

SONICATH(TM) 5 F is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corp. It received FDA 510(k) clearance on 1990-04-06 under 510(k) number K895542. 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 SONICATH(TM) 5 F?

SONICATH(TM) 5 F is a medical device that received FDA 510(k) clearance on 1990-04-06. The listed applicant is Boston Scientific Corp. The 510(k) number is K895542.

When did SONICATH(TM) 5 F receive FDA 510(k) clearance?

SONICATH(TM) 5 F received FDA 510(k) clearance on 1990-04-06, under 510(k) number K895542.

Who is the listed applicant for SONICATH(TM) 5 F?

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

What is the FDA product code for SONICATH(TM) 5 F?

The FDA product code for SONICATH(TM) 5 F is DQO.

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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

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