JMS EXTENSION SET WITH PLANECTA, PLANECTA (STAND ALONE UNIT), PLANECTA LOCK & PLANECTA ADAPTOR— 510(k) K023668
Substantially EquivalentJms North America Corp.
FDA 510(k) clearance K023668 for JMS EXTENSION SET WITH PLANECTA, PLANECTA (STAND ALONE UNIT), PLANECTA LOCK & PLANECTA ADAPTOR, Substantially Equivalent on 2003-07-01. Applicant: Jms North America Corp.. Device class: 2.
Clearance details
- Applicant
- Jms North America Corp.
- Product code
- Code FPA
- Device class
- Class 2
- Regulation
- 21 CFR 880.5440
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hayward, CA, US
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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 FPA
product code FPA- Death
- 95
- Injury
- 14,421
- Malfunction
- 125,815
- Other
- 30
- Total
- 140,361
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.