FDA 510(k)

HEPARIN IV FLUSH SYRINGE, 10 U/ML \

K-Number: K990390 · 1999-12-10

Decision Date1999-12-10

Product CodeFOZ

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

HEPARIN IV FLUSH SYRINGE, 10 U/ML \ 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 1999-12-10 under 510(k) number K990390. 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 HEPARIN IV FLUSH SYRINGE, 10 U/ML \?

HEPARIN IV FLUSH SYRINGE, 10 U/ML \ is a medical device that received FDA 510(k) clearance on 1999-12-10. The listed applicant is Rocap Div. of Sabratek Corp.. The 510(k) number is K990390.

When did HEPARIN IV FLUSH SYRINGE, 10 U/ML \ receive FDA 510(k) clearance?

HEPARIN IV FLUSH SYRINGE, 10 U/ML \ received FDA 510(k) clearance on 1999-12-10, under 510(k) number K990390.

Who is the listed applicant for HEPARIN IV FLUSH SYRINGE, 10 U/ML \?

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 HEPARIN IV FLUSH SYRINGE, 10 U/ML \?

The FDA product code for HEPARIN IV FLUSH SYRINGE, 10 U/ML \ 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

K990308ROCAP HEPARIN IV FLUSH SYRINGE, 100U/ML K984614NORMAL SALINE FLUSH SYRINGE

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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.