HEPARIN LOCK FLUSH SOLUTION USP, MODELS 504401, 504411, 504505, 505701, 504901, 1710— 510(k) K092938
Substantially EquivalentApp Pharmaceuticals, LLC
FDA 510(k) clearance K092938 for HEPARIN LOCK FLUSH SOLUTION USP, MODELS 504401, 504411, 504505, 505701, 504901, 1710, Substantially Equivalent on 2010-06-18. Applicant: App Pharmaceuticals, LLC. Device class: 2.
Clearance details
- Applicant
- App Pharmaceuticals, LLC
- Product code
- Code NZW
- Device class
- Class 2
- Regulation
- 21 CFR 880.5200
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Appollo Beach, FL, US
Recent devices under product code NZW
view all- K163591 — BD PosiFlush Heparin Lock Flush Syringe
- K133446 — HEPARIN LOCK / FLUSH SYRINGES
- K092491 — MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE 1 UNIT/ML; 10 UNITS/ML; AND 100 UNITS/ML IN VARIOUS FILL SIZES
- K090680 — HEPARIN LOCK FLUSH SOLUTION, USP BD POSIFLUSH HEPARIN LOCK FLUSH SYRINGE
- K061497 — SYREX HEPARIN LOCK FLUSH SYRINGE, 1 UNIT/ML & 2 UNITS/ML
Recalls naming K092938
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K092938.
Data sourced from openFDA. This site is unofficial and independent of the FDA.