PROTECTOR 21, PROTECTOR 50, PROTECTOR 14, INJECTOR LUER LOCK, INFUSION ADAPTER
FDA 510(k) clearance K001368 · decided 2000-05-12
Clearance details
- K-number
- K001368
- Device name
- PROTECTOR 21, PROTECTOR 50, PROTECTOR 14, INJECTOR LUER LOCK, INFUSION ADAPTER
- Applicant
- Carmel Pharma Ab.
- Decision
- Substantially Equivalent
- Date received
- 2000-05-01
- Decision date
- 2000-05-12
- Days to decision
- 11 days
- Clearance type
- Special
- Product code
- LHI
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Gothenburg, SE
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Carmel Pharma Ab.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| PhaSeal, Protector 14, Item No. P14, US Order No. 21320 recall (Z-1178-2007) | Carmel Pharma, Inc. | 2007-08-22 |
| PhaSeal Injector Luer Lock, Item No. 31, US Order No. 10310 recall (Z-1179-2007) | Carmel Pharma, Inc. | 2007-08-22 |
| PhaSeal, Protector 21, Item No. 21, US Order No. 22020 recall (Z-1180-2007) | Carmel Pharma, Inc. | 2007-08-22 |
| PhaSeal, Protector 50, Item No. 50, US Order No. 10310 recall (Z-1181-2007) | Carmel Pharma, Inc. | 2007-08-22 |