PLUME SAFETY AVF NEEDLE— 510(k) K040247
Substantially EquivalentJms North America Corp.
FDA 510(k) clearance K040247 for PLUME SAFETY AVF NEEDLE, Substantially Equivalent on 2004-03-03. Applicant: Jms North America Corp.. Device class: 2.
Clearance details
- Applicant
- Jms North America Corp.
- Product code
- Code FIE
- Device class
- Class 2
- Regulation
- 21 CFR 876.5540
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Hayward, CA, US
Recent devices under product code FIE
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- K171505 — Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series)
- K163025 — DORA Disposable A.V. Fistula Needle Sets
More 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 FIE
product code FIE- Death
- 2
- Total
- 2
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.