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FDA 510(k)

ASC HIGH PRESSURE BRAIDED TUBES

K-Number: K964331 · 1997-01-13

ApplicantAdam Spencer Corp.
Decision Date1997-01-13
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ASC HIGH PRESSURE BRAIDED TUBES is the device name listed in this FDA 510(k) record. The listed applicant is Adam Spencer Corp.. It received FDA 510(k) clearance on 1997-01-13 under 510(k) number K964331. 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 ASC HIGH PRESSURE BRAIDED TUBES?

ASC HIGH PRESSURE BRAIDED TUBES is a medical device that received FDA 510(k) clearance on 1997-01-13. The listed applicant is Adam Spencer Corp.. The 510(k) number is K964331.

When did ASC HIGH PRESSURE BRAIDED TUBES receive FDA 510(k) clearance?

ASC HIGH PRESSURE BRAIDED TUBES received FDA 510(k) clearance on 1997-01-13, under 510(k) number K964331.

Who is the listed applicant for ASC HIGH PRESSURE BRAIDED TUBES?

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

What is the FDA product code for ASC HIGH PRESSURE BRAIDED TUBES?

The FDA product code for ASC HIGH PRESSURE BRAIDED TUBES is DQO.

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Other records listing Adam Spencer 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.

K963092MAXI-TORQUE PLUS SOFTIP 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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