INTERLINK SYSTEM EXTENSION SET WITH CONTROL-A-FLO-REGULATORY CLEARLINK SYSTEM EXTENSION SET WITH CONTROL-A-FLO-REGULATOR— 510(k) K121634
Substantially EquivalentBaxter Healthcare Corporation
FDA 510(k) clearance K121634 for INTERLINK SYSTEM EXTENSION SET WITH CONTROL-A-FLO-REGULATORY CLEARLINK SYSTEM EXTENSION SET WITH CONTROL-A-FLO-REGULATOR, Substantially Equivalent on 2012-06-29. Applicant: Baxter Healthcare Corporation. Device class: 2.
Clearance details
- Applicant
- Baxter Healthcare Corporation
- 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
- Special
- Location
- Round Lake, IL, US
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More clearances from Baxter Healthcare Corporation
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- K251636 — Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)
- K251640 — SIGMA Spectrum Infusion Pump with Master Drug Library
- K243529 — Solution Administration Sets
- K242339 — Intravascular Extension Sets and Accessories
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.