MEDCOMP REPAIR KIT, MODEL ASPCRPK— 510(k) K022570
Substantially EquivalentMedcomp
FDA 510(k) clearance K022570 for MEDCOMP REPAIR KIT, MODEL ASPCRPK, Substantially Equivalent on 2002-10-31. Applicant: Medcomp. Device class: 2.
Clearance details
- Applicant
- Medcomp
- 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
- Harleysville, PA, US
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- K062435 — REPAIR KIT FOR XPRESSO, DECATHLON, AND ALTA LR CATHETERS
- K030442 — CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000
More clearances from Medcomp
view allRecalls naming K022570
K-number listed on FDA's recall record- Z-1118-2018 — CATHETER REPAIR KIT, REF AAC52001, UDI 884908001891 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
- Z-1119-2018 — REPAIR KIT, REF ARA101, UDI 884908083637 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
- Z-1120-2018 — 12F X 40CM TESIO CATHETER SET WITH "Y" ADAPTOR, REF CMD755, UDI 884908005530 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
- Z-1122-2018 — 12F Tesio CATHETER SET (CUFF 22CM FROM TIP), REF MCTC1235SD, UDI 884908027242 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
- Z-1123-2018 — 12F MODIFIED Tesio CATHETER SET, REF MCTC1235SM, UDI 884908027259 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
- Z-1124-2018 — 12F Tesio CATHETER SET (CUFF 32CM FROM TIP), REF MCTC1247SD, UDI 884908027266 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
- Z-1125-2018 — TWO PART ADAPTER, REF MCTLA2000, UDI 884908027310 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
- Z-1126-2018 — CATHETER REPAIR KIT, REF RMS52001, UDI 884908039658 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
- Z-1127-2018 — REPAIR KIT, REF RPK-01, UDI 884908039856 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K022570.
Data sourced from openFDA. This site is unofficial and independent of the FDA.