PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES— 510(k) K945777

Substantially Equivalent

Smiths Industries Medical Systems, Inc.

FDA 510(k) clearance K945777 for PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES, Substantially Equivalent on 1994-12-22. Applicant: Smiths Industries Medical Systems, Inc..

Clearance details

Applicant: Smiths Industries Medical Systems, Inc.
Product code: Code JKA
Advisory panel: Clinical Chemistry
Date received: 1994-11-25
Decision date: 1994-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Keene, NH, US

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Adverse events under product code JKA

product code JKA

Injury: 455
Malfunction: 26,686
Other: 4
Total: 27,145

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.