POLYURETHANE INFUSION CATHETER, ALPHA CATH, MODEL PAC20, AND POLYURETHANE INFUSION CATHETER, MULTI DRIP, MODEL PMD20-6— 510(k) K061356
Substantially EquivalentAdvanced Infusion, Inc.
FDA 510(k) clearance K061356 for POLYURETHANE INFUSION CATHETER, ALPHA CATH, MODEL PAC20, AND POLYURETHANE INFUSION CATHETER, MULTI DRIP, MODEL PMD20-6, Substantially Equivalent on 2006-07-03. Applicant: Advanced Infusion, Inc.. Device class: 2.
Clearance details
- Applicant
- Advanced Infusion, Inc.
- Product code
- Code MED
- Device class
- Class 2
- Regulation
- 21 CFR 880.6885
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tempe, AZ, US
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