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FDA 510(k)

INTEGRATED DRIVE/PUMP SYSTEM

K-Number: K981636 · 1998-08-20

ApplicantLinvatec Corp.
Decision Date1998-08-20
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

INTEGRATED DRIVE/PUMP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Linvatec Corp.. It received FDA 510(k) clearance on 1998-08-20 under 510(k) number K981636. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTEGRATED DRIVE/PUMP SYSTEM?

INTEGRATED DRIVE/PUMP SYSTEM is a medical device that received FDA 510(k) clearance on 1998-08-20. The listed applicant is Linvatec Corp.. The 510(k) number is K981636.

When did INTEGRATED DRIVE/PUMP SYSTEM receive FDA 510(k) clearance?

INTEGRATED DRIVE/PUMP SYSTEM received FDA 510(k) clearance on 1998-08-20, under 510(k) number K981636.

Who is the listed applicant for INTEGRATED DRIVE/PUMP SYSTEM?

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

What is the FDA product code for INTEGRATED DRIVE/PUMP SYSTEM?

The FDA product code for INTEGRATED DRIVE/PUMP SYSTEM is HRX.

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Related Devices (Code: HRX)

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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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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