CHURCHILL PARENTERAL NUTRITION BAG - EVA
FDA 510(k) clearance K870395 · decided 1987-10-15
Clearance details
- K-number
- K870395
- Device name
- CHURCHILL PARENTERAL NUTRITION BAG - EVA
- Applicant
- Churchill Corp.
- Decision
- Substantially Equivalent
- Date received
- 1987-01-30
- Decision date
- 1987-10-15
- Days to decision
- 258 days
- Clearance type
- Traditional
- Product code
- KPE
- Device class
- 2
- Regulation number
- 880.5025
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Langhorne, PA, US
- Third-party review
- No
- Expedited review
- No
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| eZSURE™ Empty Fluid Container with ProSeal™ Injection Site (K241442) | Epic Medical Pte. , Ltd. | 2024-06-21 |
| eZSURE™ Empty Fluid Container (models 426030, 426040, 426110) (K223674) | Epic Medical Pte. , Ltd. | 2023-09-01 |
| Disposable Infusion Bag for Parenteral Nutrition (K222622) | Beijing L&Z Medical Technology Development Co., Ltd. | 2023-02-16 |
| Empty EVA Bag (K210749) | Haemotronic S.P.A. | 2021-08-19 |
| SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL (K201936) | Gilero, LLC | 2021-05-06 |
| Empty EVA Bag (K193528) | Haemotronic S.P.A. | 2020-07-22 |
| HCT Empty EVA Container Pack (K190328) | Health Care Technologies | 2019-08-15 |
Recalls involving this device
No recalls on record reference this clearance.