HEMO-CATH SILICONE DOUBLE LUMEN CATH SL28C & SL40C
FDA 510(k) clearance K893439 · decided 1989-06-13
Clearance details
- K-number
- K893439
- Device name
- HEMO-CATH SILICONE DOUBLE LUMEN CATH SL28C & SL40C
- Applicant
- Medical Components, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-05-03
- Decision date
- 1989-06-13
- Days to decision
- 41 days
- Clearance type
- Traditional
- Product code
- LFJ
- 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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Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MEDSURG INSERTION TRAY (K920780) | Medsurg Industries, Inc. | 1994-08-19 |
| AKCESS0CATH KIT (K925819) | Akcess Medical Products, Inc. | 1994-08-02 |
| AKCESS-CATH (K925818) | Akcess Medical Products, Inc. | 1994-04-05 |
| ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET/TRAY (K913468) | Cook, Inc. | 1994-03-24 |
| COAXIAL ACUTE CATHETER (K931120) | Akcess Medical Products, Inc. | 1994-01-14 |
| SPLITTABLE SHEATH INTRODUCER SET (K920634) | Akcess Medical Products, Inc. | 1994-01-14 |
| VAS-CATH FLEXXICON 2 DUAL LUMEN DIALYSIS CATHETERS (K914162) | Vas-Cath, Inc. | 1993-07-01 |
| HEMO-CATH SILICONE ACCESS CATHETER (K915423) | Medical Components, Inc. | 1993-02-02 |
| AKCESS-CATH KIT (K914826) | Akcess Medical Products, Inc. | 1992-04-10 |
| PERMANENT SILICONE CATHETERS (K910501) | Akcess Medical Products, Inc. | 1991-04-29 |
| MED-WEST DUAL LUMEN INTERNAL JUGULAR CATHETER (K905080) | Kendall Healthcare Products Co. Div.Of Tyco Health | 1991-01-31 |
| SINGLE LUMEN CATHETER KITS (K904139) | Akcess Medical Products, Inc. | 1990-12-04 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Hemodialysis Catheters and PICCs: Product identification: MCDLTSL24P (SF X 24CM LT HEMO-CA recall (Z-1083-2015) | Medical Components, Inc dba MedComp | 2015-02-10 |