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FDA 510(k)

NOVOSTE 4, 4.2, 5 AND 6 FRENCH CATHETERS

K-Number: K875127 · 1988-08-09

ApplicantNovoste Corp.
Decision Date1988-08-09
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NOVOSTE 4, 4.2, 5 AND 6 FRENCH CATHETERS is the device name listed in this FDA 510(k) record. The listed applicant is Novoste Corp.. It received FDA 510(k) clearance on 1988-08-09 under 510(k) number K875127. 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 NOVOSTE 4, 4.2, 5 AND 6 FRENCH CATHETERS?

NOVOSTE 4, 4.2, 5 AND 6 FRENCH CATHETERS is a medical device that received FDA 510(k) clearance on 1988-08-09. The listed applicant is Novoste Corp.. The 510(k) number is K875127.

When did NOVOSTE 4, 4.2, 5 AND 6 FRENCH CATHETERS receive FDA 510(k) clearance?

NOVOSTE 4, 4.2, 5 AND 6 FRENCH CATHETERS received FDA 510(k) clearance on 1988-08-09, under 510(k) number K875127.

Who is the listed applicant for NOVOSTE 4, 4.2, 5 AND 6 FRENCH CATHETERS?

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

What is the FDA product code for NOVOSTE 4, 4.2, 5 AND 6 FRENCH CATHETERS?

The FDA product code for NOVOSTE 4, 4.2, 5 AND 6 FRENCH CATHETERS is DQO.

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Other records listing Novoste Corp. 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.

K942977NOVOSTE PULSE PLUS BLOOD CONTAINMENT DEVICEK911527NOVOSTE GUIDING CATHETERK900460MODIFIED NOVOSTE ANGIOGRAPHIC CATHETERK896690MODIFIED ANGIOGRAPHIC CATHETER

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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