MERIT HI-FLEX(TM)— 510(k) K883718
Substantially EquivalentMerit Medical Systems, Inc.
FDA 510(k) clearance K883718 for MERIT HI-FLEX(TM), Substantially Equivalent on 1989-01-30. Applicant: Merit Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Merit Medical Systems, Inc.
- Product code
- Code FPK
- Device class
- Class 2
- Regulation
- 21 CFR 880.5440
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Salt Lake City, UT, US
Recent devices under product code FPK
view all- K131517 — MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBING
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- K063239 — LIFESHIELD LATEX-FREE GRAVITECH FLOW CONTROLLER I.V. SETS, MODELS 17528, 17527, 17525 & 17526
- K052431 — MEDTRONIC MINIMED LEAPFROG II INFUSION SET, MODELS MMT-801S1, MMT-801L1, MMT-801S2, MMT-801L2, MMT-803S1
- K041178 — EMPOWER TRANSFER SET, (CAT. NO. 7725)
More clearances from Merit Medical Systems, Inc.
view allRecalls naming K883718
K-number listed on FDA's recall record- Z-2293-2025 — High Pressure Tubing: REF: 502211002, HP9720E/C, HP9721E/C
- Z-1319-2014 — Pressure Monitoring Tubing, PM6006. Pressure Monitoring Tubing (PM series) is used between the manifold and transducer as a conduit to transmit the fluid pressure of the patient to the pressure transducer.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K883718.
Data sourced from openFDA. This site is unofficial and independent of the FDA.