MODIFICATION TO IV SPIKE
FDA 510(k) clearance K921860 · decided 1992-07-30
Clearance details
- K-number
- K921860
- Device name
- MODIFICATION TO IV SPIKE
- Applicant
- Mcgaw, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-03-11
- Decision date
- 1992-07-30
- Days to decision
- 141 days
- Clearance type
- Traditional
- Product code
- FPA
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Outlook Safety Infusion System Burette Set. For intravenous fluid administration. recall (Z-2166-2013) | B. Braun Medical, Inc. | 2013-09-06 |
| Horizon Pump Set w/150 ml burette w/15 um filter and Ultrasite inj site, 2 Ultrasite inj s recall (Z-2407-2008) | B. Braun Medical, Inc. | 2008-09-23 |
| Adult Metriset w/Cassette 2 inj sites, LL 120 in. Item/Catalog number 375043. The product recall (Z-2408-2008) | B. Braun Medical, Inc. | 2008-09-23 |
| Safeline Metriset w/Cassette, inj sties, clamps LL 114 in. Item/Catalog number 375122. The recall (Z-2409-2008) | B. Braun Medical, Inc. | 2008-09-23 |
| Burette Set w/150 ml Burette w/15 um filter & Ultrasite inj site, Ultrasite inj site, 88 i recall (Z-2411-2008) | B. Braun Medical, Inc. | 2008-09-23 |
| Burette Set w/150 ml burette w/15 um filter & inj site, inj site, with automatic shutoff 8 recall (Z-2414-2008) | B. Braun Medical, Inc. | 2008-09-23 |