FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEDCOMP ASH SPLIT
K Number: K011576
·
Decision Jun 21, 2001
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
10
Applicant Total
46
Review Days
30
Basic Information
- Device Name
- MEDCOMP ASH SPLIT
- K Number
- K011576
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.5540
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MEDICAL COMPONENTS, INC.
- Date Received
- May 22, 2001
- Decision Date
- June 21, 2001
- Product Code
- NFK
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NFK | Kit, Repair, Catheter, Hemodialysis | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NFK), ordered by most recent decision date.
CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000
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Other Clearances by MEDICAL COMPONENTS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K012562 | MEDCOMP 14.5F DOUBLE LUMEN HEMODIALYSIS CATHETER | Feb 8, 2002 | Substantially Equivalent |
| K994105 | HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-24, HFS-28, HFS-32, HFS-36, HFS-40 | Oct 3, 2001 | Substantially Equivalent |
| K003207 | MEDCOMP ULTRA-FLOW CATHETER | Jun 12, 2001 | Substantially Equivalent |
| K010021 | MEDCOMP QUAD LUMEN, 8.5F X 20CM, MODEL MC4L-8S | Feb 23, 2001 | Substantially Equivalent |
| K003682 | MEDCOMP Z-CATH | Jan 26, 2001 | Substantially Equivalent |
| K991320 | MEDCOMP DUO-FLOW II CATHETER WITH LUBRICIOUS HEPARIN | Nov 10, 1999 | Substantially Equivalent |
| K980438 | 11.5F X 6 (15CM) DUO-SPLIT CATHETER MCDS116MT, 11.5F X 8 (20CM) DUO-SPLIT CATHETER MCDS118MT | Jun 10, 1999 | Substantially Equivalent |
| K983511 | SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 12CM, SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 15CM, SOFT-LINE LUMEN CATH | Jun 8, 1999 | Substantially Equivalent |
| K974236 | MEDCOMP SCHON XL SOFT-LINE DOUBLE LUMEN CATHETER, 15CM SBF146, MEDCOMP SCHON XL SOFT-LINE DOUBLE LUMEN CATHETER, 20CM SB | Apr 15, 1999 | Substantially Equivalent |
| K981125 | MEDCOMP TESIO CATHETER, MODELS MBR-6, MBL-6, MBS-6 | Feb 26, 1999 | Substantially Equivalent |