MEDCOMP SCHON XL SOFT-LINE DOUBLE LUMEN CATHETER, 15CM SBF146, MEDCOMP SCHON XL SOFT-LINE DOUBLE LUMEN CATHETER, 20CM SB
FDA 510(k) clearance K974236 · decided 1999-04-15
Clearance details
- K-number
- K974236
- Device name
- MEDCOMP SCHON XL SOFT-LINE DOUBLE LUMEN CATHETER, 15CM SBF146, MEDCOMP SCHON XL SOFT-LINE DOUBLE LUMEN CATHETER, 20CM SB
- Applicant
- Medical Components, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-11-12
- Decision date
- 1999-04-15
- Days to decision
- 519 days
- Clearance type
- Traditional
- Product code
- MPB
- Device class
- 2
- Regulation number
- 876.5540
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Harleysville, PA, US
- Third-party review
- No
- Expedited review
- No
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| Zenysis Short-Term Dialysis Catheter (K163458) | C.R. Bard, Inc. | 2017-04-04 |
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| Zenysis Short-Term Dialysis Catheter (K153190) | C.R. Bard, Inc. | 2016-01-05 |
| COOK TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY COOK SPECTRUM TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY (K122091) | Cook, Inc. | 2013-07-29 |
| MAHURKAR ELITE ACUTE DUAL LUMEN CATHETER, ELITE ACUTE TRIPLE LUMEN CATHETER (K120674) | Covidien | 2012-04-04 |
| AMECATH AND AMECATH UNIQATH SOFT SHORT TERM DUAL HEMODIALYSIS CATHETERIZATION KITS (K110793) | Ameco Medical Industries | 2011-12-16 |
| DISPOSABLE HEMODIALYSIS ACCESS CATHETER SETS (K102833) | Foshan Nanhai Bai HE Medical Technology Co., Ltd. | 2011-11-18 |
| GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1315 A; AND MS-GDHC-1315J A, GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1320 A; AND MS-GDHC-132 (K100451) | Gambro Renal Products, Inc. | 2010-12-21 |
Recalls involving this device
No recalls on record reference this clearance.