ALPHA INFUSION PUMP AND CATHETERS— 510(k) K021964
Substantially EquivalentAdvanced Infusion, Inc.
FDA 510(k) clearance K021964 for ALPHA INFUSION PUMP AND CATHETERS, Substantially Equivalent on 2002-08-12. Applicant: Advanced Infusion, Inc.. Device class: 2.
Clearance details
- Applicant
- Advanced Infusion, Inc.
- Product code
- Code MEB
- Device class
- Class 2
- Regulation
- 21 CFR 880.5725
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tempe, AZ, US
Recent devices under product code MEB
view allMore clearances from Advanced Infusion, Inc.
view all- K071532 — ALPHA INFUSION PUMP, MODEL A200, A450
- K061661 — STA CATH ATTACHABLE INFISION CATHETER, MODEL STA20
- K061356 — POLYURETHANE INFUSION CATHETER, ALPHA CATH, MODEL PAC20, AND POLYURETHANE INFUSION CATHETER, MULTI DRIP, MODEL PMD20-6
- K042246 — MULTI-DRIP INFUSION CATHETER
- K992551 — ALPHA INFUSION PUMP
Adverse events under product code MEB
product code MEB- Death
- 6
- Injury
- 160
- Malfunction
- 10,053
- Other
- 5
- Total
- 10,224
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.