PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES— 510(k) K945777
Substantially EquivalentSmiths 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.. Device class: 2.
Clearance details
- Applicant
- Smiths Industries Medical Systems, Inc.
- Product code
- Product code JKA
- Device class
- Class 2
- Regulation
- 21 CFR 862.1675
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Keene, NH, US
Recent devices under product code JKA
view all- K262242 — Profoject Safe Push Button Blood Collection Sets
- K260857 — Sol-Guard Safety Pull Button Collection Set; Sol-Guard XtraThin Safety Pull-Button Blood Collection Set
- K252344 — BD Vacutainer® Serum Blood Collection Tubes; BD Vacutainer® Rapid Serum Tubes (RST)
- K262215 — Profoject Safety Sliding Blood Collection Set
- K252899 — Female Culture Device; Male Culture Device; Transfer Device; Access Device
More clearances from Smiths Industries Medical Systems, Inc.
view allAdverse events under product code JKA
product code JKA- Injury
- 455
- Malfunction
- 26,686
- Other
- 4
- Total
- 27,145
Source: openFDA MAUDE database, through . 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.