MEDCOMP Z-CATH
FDA 510(k) clearance K003682 · decided 2001-01-26
Clearance details
- K-number
- K003682
- Device name
- MEDCOMP Z-CATH
- Applicant
- Medical Components, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-11-30
- Decision date
- 2001-01-26
- Days to decision
- 57 days
- Clearance type
- Traditional
- Product code
- LJS
- Device class
- 2
- Regulation number
- 880.5970
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Harleysville, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Jet Medical 4F x 60cm Single Lumen Polyurethane PICC Nursing Tray. Catalog number JDMPN4S- recall (Z-0103-06) | Medical Components, Inc dba MedComp | 2005-10-28 |
| Jet Medical 4F Single Lumen PICC Kit. Catalog number JP7-4 recall (Z-0104-06) | Medical Components, Inc dba MedComp | 2005-10-28 |