JMS SYSLOC A.V. FISTULA NEEDLE SET, JMS SYSLOC APHERESIS NEEDLE SET— 510(k) K030479
Substantially EquivalentJms North America Corp.
FDA 510(k) clearance K030479 for JMS SYSLOC A.V. FISTULA NEEDLE SET, JMS SYSLOC APHERESIS NEEDLE SET, Substantially Equivalent on 2003-08-18. Applicant: Jms North America Corp.. Device class: 2.
Clearance details
- Applicant
- Jms North America Corp.
- Product code
- Code FOZ
- Device class
- Class 2
- Regulation
- 21 CFR 880.5200
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hayward, CA, US
Recent devices under product code FOZ
view allMore clearances from Jms North America Corp.
view all- K093637 — JMS BLUNT A. V. FISTULA NEEDLE SET WITH SITE PREPARATION TOOL MODEL 820-5300, 820-6300 AND 820-7300
- K082882 — A.V. FISTULA BLUNT NEEDLE SET
- K070234 — JMS SYSLOC MINI AVF AND APHERESIS NEEDLE SETS
- K070143 — JMS PLANECTA STOPCOCK
- K051814 — JMS SYSLOC MINI A.V. FISTULA NEEDLE SET AND APHERESIS NEEDLE SET
Adverse events under product code FOZ
product code FOZ- Death
- 38
- Injury
- 2,290
- Malfunction
- 25,858
- Other
- 11
- Total
- 28,197
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.