LIFEGUARD SAFETY INFUSION SET— 510(k) K013871
Substantially EquivalentHorizon Medical Products, Inc.
FDA 510(k) clearance K013871 for LIFEGUARD SAFETY INFUSION SET, Substantially Equivalent on 2002-03-29. Applicant: Horizon Medical Products, Inc.. Device class: 2.
Clearance details
- Applicant
- Horizon Medical Products, Inc.
- 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
- Manchester, GA, US
Recent devices under product code FPA
view all- K254123 — Ecomed Disposable Administration Sets
- K261530 — iiSure Infusion Set
- K252543 — AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)
- K251375 — PuraCath Firefly Needleless Connector IT (9005)
- K251257 — nSet+ Stabilization Set [6426733] +2 more
More clearances from Horizon Medical Products, Inc.
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 →
Recalls naming K013871
K-number listed on FDA's recall record- Z-0679-2018 — 20Ga x .75 LifeGuard Huber Needle with Y-site. Product Code: CLGY-2034.
- Z-0914-2013 — Lifeguard Infusion Set with Smartsite, 20Ga, 1, CLGY-2010 Huber type needle set used for the infusion of medical fluids into implantable ports.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K013871.
Data sourced from openFDA. This site is unofficial and independent of the FDA.