FDA 510(k)

PRO-VENT, PULSATOR ARTERIAL BLOOD SAMPLING SYRINGES

K-Number: K981035 · 1998-04-21

Decision Date1998-04-21

Product CodeJKA

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

PRO-VENT, PULSATOR ARTERIAL BLOOD SAMPLING SYRINGES is the device name listed in this FDA 510(k) record. The listed applicant is Sims Portex, Inc.. It received FDA 510(k) clearance on 1998-04-21 under 510(k) number K981035. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRO-VENT, PULSATOR ARTERIAL BLOOD SAMPLING SYRINGES?

PRO-VENT, PULSATOR ARTERIAL BLOOD SAMPLING SYRINGES is a medical device that received FDA 510(k) clearance on 1998-04-21. The listed applicant is Sims Portex, Inc.. The 510(k) number is K981035.

When did PRO-VENT, PULSATOR ARTERIAL BLOOD SAMPLING SYRINGES receive FDA 510(k) clearance?

PRO-VENT, PULSATOR ARTERIAL BLOOD SAMPLING SYRINGES received FDA 510(k) clearance on 1998-04-21, under 510(k) number K981035.

Who is the listed applicant for PRO-VENT, PULSATOR ARTERIAL BLOOD SAMPLING SYRINGES?

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

What is the FDA product code for PRO-VENT, PULSATOR ARTERIAL BLOOD SAMPLING SYRINGES?

The FDA product code for PRO-VENT, PULSATOR ARTERIAL BLOOD SAMPLING SYRINGES is JKA.

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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.