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FDA 510(k)

NORMAL SALINE FLUSH SYRINGE

K-Number: K984614 · 1999-05-27

ApplicantRocap Div. of Sabratek Corp.
Decision Date1999-05-27
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NORMAL SALINE FLUSH SYRINGE is the device name listed in this FDA 510(k) record. The listed applicant is Rocap Div. of Sabratek Corp.. It received FDA 510(k) clearance on 1999-05-27 under 510(k) number K984614. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NORMAL SALINE FLUSH SYRINGE?

NORMAL SALINE FLUSH SYRINGE is a medical device that received FDA 510(k) clearance on 1999-05-27. The listed applicant is Rocap Div. of Sabratek Corp.. The 510(k) number is K984614.

When did NORMAL SALINE FLUSH SYRINGE receive FDA 510(k) clearance?

NORMAL SALINE FLUSH SYRINGE received FDA 510(k) clearance on 1999-05-27, under 510(k) number K984614.

Who is the listed applicant for NORMAL SALINE FLUSH SYRINGE?

The FDA 510(k) record lists Rocap Div. of Sabratek Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NORMAL SALINE FLUSH SYRINGE?

The FDA product code for NORMAL SALINE FLUSH SYRINGE is FOZ.

Related Clinical Trials

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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Other records listing Rocap Div. of Sabratek 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.

K990390HEPARIN IV FLUSH SYRINGE, 10 U/ML \K990308ROCAP HEPARIN IV FLUSH SYRINGE, 100U/ML

Related Devices (Code: FOZ)

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.

K260432Ruby Intravascular CatheterVenocare, Inc.K260165Unimpregnated Central Venous CatheterSpectrum VascularK261041ClearSafe Closed SystemMedSource Labs, LLCK260539MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV CatheterMedSource Labs, LLCK253235Introcan Safety® Deep Access XL IV CatheterB.Braun Medical, Inc.K252137BD Insyte™ IV CatheterBecton Dickinson Infusion Therapy Systems, 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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