INTRAVASCULAR IV SET, IV SET WITH BURETTE, EXTENSION SET— 510(k) K001329
Substantially EquivalentLifemed of California
FDA 510(k) clearance K001329 for INTRAVASCULAR IV SET, IV SET WITH BURETTE, EXTENSION SET, Substantially Equivalent on 2001-02-14. Applicant: Lifemed of California. Device class: 2.
Clearance details
- Applicant
- Lifemed of California
- 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
- Anaheim, CA, US
Recent devices under product code FPA
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- K251375 — PuraCath Firefly Needleless Connector IT (9005)
- K251257 — nSet+ Stabilization Set [6426733] +2 more
More clearances from Lifemed of California
view allAdverse 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.