FDA 510(k)

PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES

K-Number: K945777 · 1994-12-22

ApplicantSmiths Industries Medical Systems, Inc.

Decision Date1994-12-22

Product CodeJKA

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES is the device name listed in this FDA 510(k) record. The listed applicant is Smiths Industries Medical Systems, Inc.. It received FDA 510(k) clearance on 1994-12-22 under 510(k) number K945777. 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(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES?

PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES is a medical device that received FDA 510(k) clearance on 1994-12-22. The listed applicant is Smiths Industries Medical Systems, Inc.. The 510(k) number is K945777.

When did PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES receive FDA 510(k) clearance?

PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES received FDA 510(k) clearance on 1994-12-22, under 510(k) number K945777.

Who is the listed applicant for PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES?

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

What is the FDA product code for PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES?

The FDA product code for PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES is JKA.

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Other records listing Smiths Industries Medical Systems, Inc. as applicant

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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.