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FDA 510(k)

ACURA ELITE GRAVITY COMPENSATING RESERVOIR

K-Number: K030468 · 2003-10-15

ApplicantPhoenix Biomedical Corp.
Decision Date2003-10-15
Product CodeJXG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ACURA ELITE GRAVITY COMPENSATING RESERVOIR is the device name listed in this FDA 510(k) record. The listed applicant is Phoenix Biomedical Corp.. It received FDA 510(k) clearance on 2003-10-15 under 510(k) number K030468. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACURA ELITE GRAVITY COMPENSATING RESERVOIR?

ACURA ELITE GRAVITY COMPENSATING RESERVOIR is a medical device that received FDA 510(k) clearance on 2003-10-15. The listed applicant is Phoenix Biomedical Corp.. The 510(k) number is K030468.

When did ACURA ELITE GRAVITY COMPENSATING RESERVOIR receive FDA 510(k) clearance?

ACURA ELITE GRAVITY COMPENSATING RESERVOIR received FDA 510(k) clearance on 2003-10-15, under 510(k) number K030468.

Who is the listed applicant for ACURA ELITE GRAVITY COMPENSATING RESERVOIR?

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

What is the FDA product code for ACURA ELITE GRAVITY COMPENSATING RESERVOIR?

The FDA product code for ACURA ELITE GRAVITY COMPENSATING RESERVOIR is JXG.

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Other records listing Phoenix Biomedical 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.

K024101PHOENIX UNIVERSAL SHUNT SYSTEMK024040ACCURA ELITE SHUNT SYSTEMK021644PERF (OMMAYA STYLE) RESERVOIRSK002476LUMBOPERITONEAL SHUNT SYSTEMK000514RUMBAR DRAINAGE SYSTEMK991429DIAMOND II VALVE

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Related Devices (Code: JXG)

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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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