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FDA 510(k)

PEDIATRIC AND INFANT CATH KITS

K-Number: K905016 · 1990-12-20

ApplicantDavol, Inc.
Decision Date1990-12-20
Product CodeFFH
Advisory CommitteeGU
DecisionUnknown

Device Summary

PEDIATRIC AND INFANT CATH KITS is the device name listed in this FDA 510(k) record. The listed applicant is Davol, Inc.. It received FDA 510(k) clearance on 1990-12-20 under 510(k) number K905016. The device is classified under product code FFH. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the PEDIATRIC AND INFANT CATH KITS?

PEDIATRIC AND INFANT CATH KITS is a medical device that received FDA 510(k) clearance on 1990-12-20. The listed applicant is Davol, Inc.. The 510(k) number is K905016.

When did PEDIATRIC AND INFANT CATH KITS receive FDA 510(k) clearance?

PEDIATRIC AND INFANT CATH KITS received FDA 510(k) clearance on 1990-12-20, under 510(k) number K905016.

Who is the listed applicant for PEDIATRIC AND INFANT CATH KITS?

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

What is the FDA product code for PEDIATRIC AND INFANT CATH KITS?

The FDA product code for PEDIATRIC AND INFANT CATH KITS is FFH.

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Other records listing Davol, Inc. 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.

K251557Bard® Mesh; Bard® Mesh Pre-ShapedK250098Bard Soft Mesh; Bard Soft Mesh Pre-ShapedK031213AQUASENS FLUID MONITORING SYSTEMK030307DAVOL ARTHROVENT OUTFLOW TUBINGK003323COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,0010205K003790DAVOL X-STREAM LAPAROSCOPIC IRRIGATION SYSTEM, MODELS 5551000, 5552000, 5552001, 552002, 5552003, 5552004, 5552005

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Related Devices (Code: FFH)

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.

K896581PEDIATRIC DRAIN BAGLaytech Medical Co.K871789INTECARE PEDIATRIC URINE COLLECTORMercury Enterprises, Inc.

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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