ACUTE AND CHRONIC CATHETER REPAIR KIT— 510(k) K092797
UnknownKendall
FDA 510(k) clearance K092797 for ACUTE AND CHRONIC CATHETER REPAIR KIT, Unknown on 2009-11-19. Applicant: Kendall. Device class: 2.
Clearance details
- Applicant
- Kendall
- Product code
- Code NFK
- Device class
- Class 2
- Regulation
- 21 CFR 876.5540
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Traditional
- Location
- Mansfield, MA, US
Recent devices under product code NFK
view all- K101261 — CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000
- 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
- K022644 — RETRO REPAIR KIT, MODEL PRRK5
More clearances from Kendall
view all- K062671 — 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING AND SILVER IMPREGNATED SLEEVE (PALINDROME SAPPHIRE)
- K060972 — KEDALL 14.5 FR CHRONIC HEMODIALYSIS CATHETER W/SILVER IMPREGNATED SLEEVE (PALINDROME RUBY)
- K053410 — GIENTRIPORT WITH UNIVERSAL SINGLE LUMEN ADAPTOR
- K051584 — 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH INSERTION STYLETS ACCESSORY
- K043272 — PALLINDROME 14.5FR CHRONIC HEMODIALYSIS CATHETER WITH SLOTTED SYMMETRICAL TIP
Recalls naming K092797
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 K092797.
Data sourced from openFDA. This site is unofficial and independent of the FDA.