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FDA 510(k)

RAPID ADD SITE DOUBLE LUMEN I.V.EXTENSION SET

K-Number: K915109 · 1992-05-08

ApplicantBallard Medical Products
Decision Date1992-05-08
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

RAPID ADD SITE DOUBLE LUMEN I.V.EXTENSION SET is the device name listed in this FDA 510(k) record. The listed applicant is Ballard Medical Products. It received FDA 510(k) clearance on 1992-05-08 under 510(k) number K915109. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RAPID ADD SITE DOUBLE LUMEN I.V.EXTENSION SET?

RAPID ADD SITE DOUBLE LUMEN I.V.EXTENSION SET is a medical device that received FDA 510(k) clearance on 1992-05-08. The listed applicant is Ballard Medical Products. The 510(k) number is K915109.

When did RAPID ADD SITE DOUBLE LUMEN I.V.EXTENSION SET receive FDA 510(k) clearance?

RAPID ADD SITE DOUBLE LUMEN I.V.EXTENSION SET received FDA 510(k) clearance on 1992-05-08, under 510(k) number K915109.

Who is the listed applicant for RAPID ADD SITE DOUBLE LUMEN I.V.EXTENSION SET?

The FDA 510(k) record lists Ballard Medical Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RAPID ADD SITE DOUBLE LUMEN I.V.EXTENSION SET?

The FDA product code for RAPID ADD SITE DOUBLE LUMEN I.V.EXTENSION SET is FPA.

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Other records listing Ballard Medical Products 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.

K030721QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLEK022398REUSABLE BRONCHIAL BIOPSY FORCEPSK013892LUTZ NEEDLEK000495BALLARD MEDICAL PRODUCTS EPIDURAL AND SPINAL NEEDLESK993138BALLARD MIC-KEY G LOW PROFILE GASTROSTOMY REPLACEMENT KITK990376BALLARD MEDICAL PRODUCTS FACILETOME BOW STRING PAPILLOTOME

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Related Devices (Code: FPA)

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.

K254123Ecomed Disposable Administration SetsEcomed Solutions, LLCK261530iiSure Infusion SetDeka Research and DevelopmentK252543AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)Amsino International, Inc.K251375PuraCath Firefly Needleless Connector IT (9005)Puracath Medical, Inc.K251257nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]Np MedicalK250325BD Alaris Pump Infusion SetCarefusion (Bd)

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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