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FDA 510(k)

EXONOX PERCUTANEOUS INTRODUCER SYSTEM W/ HEMOSTASI

K-Number: K923681 · 1993-01-21

ApplicantExonix Research Corp.
Decision Date1993-01-21
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EXONOX PERCUTANEOUS INTRODUCER SYSTEM W/ HEMOSTASI is the device name listed in this FDA 510(k) record. The listed applicant is Exonix Research Corp.. It received FDA 510(k) clearance on 1993-01-21 under 510(k) number K923681. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXONOX PERCUTANEOUS INTRODUCER SYSTEM W/ HEMOSTASI?

EXONOX PERCUTANEOUS INTRODUCER SYSTEM W/ HEMOSTASI is a medical device that received FDA 510(k) clearance on 1993-01-21. The listed applicant is Exonix Research Corp.. The 510(k) number is K923681.

When did EXONOX PERCUTANEOUS INTRODUCER SYSTEM W/ HEMOSTASI receive FDA 510(k) clearance?

EXONOX PERCUTANEOUS INTRODUCER SYSTEM W/ HEMOSTASI received FDA 510(k) clearance on 1993-01-21, under 510(k) number K923681.

Who is the listed applicant for EXONOX PERCUTANEOUS INTRODUCER SYSTEM W/ HEMOSTASI?

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

What is the FDA product code for EXONOX PERCUTANEOUS INTRODUCER SYSTEM W/ HEMOSTASI?

The FDA product code for EXONOX PERCUTANEOUS INTRODUCER SYSTEM W/ HEMOSTASI is DYB.

Related Clinical Trials

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Other records listing Exonix Research 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.

K915136ATRAUMATIC TIP ANGIOGRAPHIC CATHETER

Related Devices (Code: DYB)

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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