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FDA 510(k)

CORDGUARD BLOOD COLLECTION DEVICE

K-Number: K912419 · 1992-10-05

ApplicantO.B. Tech., Inc.
Decision Date1992-10-05
Product CodeHFW
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

CORDGUARD BLOOD COLLECTION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is O.B. Tech., Inc.. It received FDA 510(k) clearance on 1992-10-05 under 510(k) number K912419. The device is classified under product code HFW. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CORDGUARD BLOOD COLLECTION DEVICE?

CORDGUARD BLOOD COLLECTION DEVICE is a medical device that received FDA 510(k) clearance on 1992-10-05. The listed applicant is O.B. Tech., Inc.. The 510(k) number is K912419.

When did CORDGUARD BLOOD COLLECTION DEVICE receive FDA 510(k) clearance?

CORDGUARD BLOOD COLLECTION DEVICE received FDA 510(k) clearance on 1992-10-05, under 510(k) number K912419.

Who is the listed applicant for CORDGUARD BLOOD COLLECTION DEVICE?

The FDA 510(k) record lists O.B. Tech., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CORDGUARD BLOOD COLLECTION DEVICE?

The FDA product code for CORDGUARD BLOOD COLLECTION DEVICE is HFW.

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Related Devices (Code: HFW)

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.

K041332JOEY CLAMP OPENING TOOLMaternus, Inc.K033846KAEN YIH UMBILICAL CORD CLAMPKaen Yih Enterprise Co., Ltd.K020718SECURLINE UMBILICAL CORD CLAMP #3505 STERILE #3515 NON-STERILEPrecision Dynamics Corp.K021055BUSSE UMBILICAL CORD CLAMP CUTTERBusse Hospital Disposables, Inc.K012917DYNAREX UMBILICAL CORD LAMP, MODELS 6833 AND 6833-BDynarex Corp.K011621KOALA CLAMP, KOALA CLAMP AND CUTTERMaternus, Inc.

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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