INTROSTAT LEAD INTRODUCER
FDA 510(k) clearance K960200 · decided 1996-07-02
Clearance details
- K-number
- K960200
- Device name
- INTROSTAT LEAD INTRODUCER
- Applicant
- Msi, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-01-03
- Decision date
- 1996-07-02
- Days to decision
- 181 days
- Clearance type
- Traditional
- Product code
- DYB
- Device class
- 2
- Regulation number
- 870.1340
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Tarpon Springs, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Arrow A Port with Attachable Silicone Rubber Catheters/10 Fr. Introducer Kit Implantable V recall (Z-0254-04) | Arrow International Inc | 2004-07-20 |
| Arrow A Port with Attachable Silicone Rubber Catheters Implantable Vascular Access System recall (Z-0255-04) | Arrow International Inc | 2004-07-20 |
| Arrow Low Profile Port with Attachable Silicone Rubber Catheters/10 Fr. Introducer Kit Imp recall (Z-0256-04) | Arrow International Inc | 2004-07-20 |
| Arrow Low Profile Port with Attachable Silicone Rubber Catheters/10 Fr. Introducer Kit Imp recall (Z-0257-04) | Arrow International Inc | 2004-07-20 |