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FDA 510(k)

VENTRALITH I

K-Number: K883750 · 1989-01-13

ApplicantBio Pace Technology, Inc.
Decision Date1989-01-13
Product CodeDXY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VENTRALITH I is the device name listed in this FDA 510(k) record. The listed applicant is Bio Pace Technology, Inc.. It received FDA 510(k) clearance on 1989-01-13 under 510(k) number K883750. The device is classified under product code DXY. It was reviewed by the CV advisory panel. Product code DXY falls under the category of Clinical Chemistry, which covers reagents and instruments for chemical analysis of clinical samples. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VENTRALITH I?

VENTRALITH I is a medical device that received FDA 510(k) clearance on 1989-01-13. The listed applicant is Bio Pace Technology, Inc.. The 510(k) number is K883750.

When did VENTRALITH I receive FDA 510(k) clearance?

VENTRALITH I received FDA 510(k) clearance on 1989-01-13, under 510(k) number K883750.

Who is the listed applicant for VENTRALITH I?

The FDA 510(k) record lists Bio Pace Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VENTRALITH I?

The FDA product code for VENTRALITH I is DXY. This falls under the Clinical Chemistry category.

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Related Devices (Code: DXY)

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

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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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