INTRAVASCULAR ADMINISTRATION SET
FDA 510(k) clearance K991932 · decided 1999-08-20
Clearance details
- K-number
- K991932
- Device name
- INTRAVASCULAR ADMINISTRATION SET
- Applicant
- The Kipp Group
- Decision
- Substantially Equivalent
- Date received
- 1999-06-08
- Decision date
- 1999-08-20
- Days to decision
- 73 days
- Clearance type
- Traditional
- Product code
- FPA
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Ontario, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| I.V. Extension Sets; sterile, Rx, single use devices; Abbott Laboratories, North Chicago, recall (Z-0956-03) | Abbott Laboratories HPD/ADD | 2003-06-27 |
| LifeShield Latex-Free 150 mL Burette Set, Nonvented, 117 Inch with Prepierced Injection Si recall (Z-0914-03) | Abbott Laboratories HPD/ADD | 2003-06-05 |