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FDA 510(k)

HYDRO-SIL(TM) COATED GUIDEWIRES

K-Number: K900822 · 1990-07-17

ApplicantNational-Standard Medical Products
Decision Date1990-07-17
Product CodeDOX
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

HYDRO-SIL(TM) COATED GUIDEWIRES is the device name listed in this FDA 510(k) record. The listed applicant is National-Standard Medical Products. It received FDA 510(k) clearance on 1990-07-17 under 510(k) number K900822. The device is classified under product code DOX. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYDRO-SIL(TM) COATED GUIDEWIRES?

HYDRO-SIL(TM) COATED GUIDEWIRES is a medical device that received FDA 510(k) clearance on 1990-07-17. The listed applicant is National-Standard Medical Products. The 510(k) number is K900822.

When did HYDRO-SIL(TM) COATED GUIDEWIRES receive FDA 510(k) clearance?

HYDRO-SIL(TM) COATED GUIDEWIRES received FDA 510(k) clearance on 1990-07-17, under 510(k) number K900822.

Who is the listed applicant for HYDRO-SIL(TM) COATED GUIDEWIRES?

The FDA 510(k) record lists National-Standard Medical Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HYDRO-SIL(TM) COATED GUIDEWIRES?

The FDA product code for HYDRO-SIL(TM) COATED GUIDEWIRES is DOX.

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 National-Standard Medical Products 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.

K896606JACKSON FINE NEEDLE ASPIRATION SYSTEMK896605KOPANS STABILIZED NEEDLE ASPIRATION GUIDE (SNAG)

Related Devices (Code: DOX)

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.

K014195KAYAK HYDROPHILIC GUIDE WIRESBoston Scientific CorpK944226MSI PROCEDURE KITMsi, Inc.K832030HEPARIN COATED STAINLESS STEEL/TEFLONArgon Medical Corp.

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.

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