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FDA 510(k)

GHAJAR INTRAVENTRICULAR CATHETER GUIDE

K-Number: K854475 · 1986-02-20

ApplicantSparta Instrument Corp.
Decision Date1986-02-20
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

GHAJAR INTRAVENTRICULAR CATHETER GUIDE is the device name listed in this FDA 510(k) record. The listed applicant is Sparta Instrument Corp.. It received FDA 510(k) clearance on 1986-02-20 under 510(k) number K854475. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GHAJAR INTRAVENTRICULAR CATHETER GUIDE?

GHAJAR INTRAVENTRICULAR CATHETER GUIDE is a medical device that received FDA 510(k) clearance on 1986-02-20. The listed applicant is Sparta Instrument Corp.. The 510(k) number is K854475.

When did GHAJAR INTRAVENTRICULAR CATHETER GUIDE receive FDA 510(k) clearance?

GHAJAR INTRAVENTRICULAR CATHETER GUIDE received FDA 510(k) clearance on 1986-02-20, under 510(k) number K854475.

Who is the listed applicant for GHAJAR INTRAVENTRICULAR CATHETER GUIDE?

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

What is the FDA product code for GHAJAR INTRAVENTRICULAR CATHETER GUIDE?

The FDA product code for GHAJAR INTRAVENTRICULAR CATHETER GUIDE is HAW.

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.

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Other records listing Sparta Instrument 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.

K781365SPARTA BRONCHIAL BRUSHK780258MILK BATH CONCENTRATEK780257MICROSPEARS

Related Devices (Code: HAW)

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.

K253856Geniant Cranial (Navigated Neurosurgical Positioning Robot)Koh Young Technology, Inc.K261932Leksell® Vantage Stereotactic SystemElekta Solutions ABK253663Zeta Navigation SystemZeta Surgical, Inc.K253379Stealth AXiS Cranial clinical applicationMedtronic Navigation, Inc.K231897NeuroAlign softwareMedivis, Inc.K251317SOLOPASS 2.0 SystemIntravent Medical Partners

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.

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