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FDA 510(k)

EPIDURAL MINIPACK

K-Number: K924541 · 1993-07-09

ApplicantConcord/Portex
Decision Date1993-07-09
Product CodeBYO
Advisory CommitteeAN
DecisionUnknown

Device Summary

EPIDURAL MINIPACK is the device name listed in this FDA 510(k) record. The listed applicant is Concord/Portex. It received FDA 510(k) clearance on 1993-07-09 under 510(k) number K924541. The device is classified under product code BYO. It was reviewed by the AN advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the EPIDURAL MINIPACK?

EPIDURAL MINIPACK is a medical device that received FDA 510(k) clearance on 1993-07-09. The listed applicant is Concord/Portex. The 510(k) number is K924541.

When did EPIDURAL MINIPACK receive FDA 510(k) clearance?

EPIDURAL MINIPACK received FDA 510(k) clearance on 1993-07-09, under 510(k) number K924541.

Who is the listed applicant for EPIDURAL MINIPACK?

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

What is the FDA product code for EPIDURAL MINIPACK?

The FDA product code for EPIDURAL MINIPACK is BYO.

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Other records listing Concord/Portex 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.

K923559STERI-CATH MDIK930218SUBCUTANEOUS TUNNELING NEEDLE AND HANDLESK930286DRI-VENDT/PROVENT/ACCUVENT ARTERIAL BLOOD GAS KITSK923127NEEDLE-PRO CARTRIDGEK923910HEAT MOISTURE CONDENSERK922749LOW PROFILE TRACHEOSTOMY TUBE

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Related Devices (Code: BYO)

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.

K913527HYPERFREEKist Intl.K780558BOTTLE BREATHING DEVICEB & F Medical Products, Inc.K7804072C7125 BLOW BOTTLETravenol Laboratories, S.A.

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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