DIATEK CONNECTOR ASSEMBLY REPLACEMENT KIT (CARK)— 510(k) K020430
Substantially EquivalentDiatek, Inc.
FDA 510(k) clearance K020430 for DIATEK CONNECTOR ASSEMBLY REPLACEMENT KIT (CARK), Substantially Equivalent on 2002-05-09. Applicant: Diatek, Inc.. Device class: 2.
Clearance details
- Applicant
- Diatek, Inc.
- Product code
- Code NFK
- Device class
- Class 2
- Regulation
- 21 CFR 876.5540
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Winston-Salem, NC, US
Recent devices under product code NFK
view all- K101261 — CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000
- K092797 — ACUTE AND CHRONIC CATHETER REPAIR KIT
- K063446 — CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000
- K062435 — REPAIR KIT FOR XPRESSO, DECATHLON, AND ALTA LR CATHETERS
- K030442 — CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000
More clearances from Diatek, Inc.
view allRecalls naming K020430
K-number listed on FDA's recall record- Z-2802-2020 — Cannon II Plus Replacement Hub Set - Product Usage: is indicated for use in the replacement of a Cannon II Plus hub connection assembly that has been damaged.
- Z-2804-2020 — NextStep Retrograde Replacement Hub Set - Product Usage: is indicated for use in the replacement of a NextStep Retrograde hub connection assembly that has been damaged.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K020430.
Data sourced from openFDA. This site is unofficial and independent of the FDA.