Piston Syringe With Neuraxial Connector – Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact
QEH is the FDA product code for Piston Syringe With Neuraxial Connector – Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact, a class II device type, regulated under 21 CFR 880.5860. FDA's definition for this code reads: "A neuraxial piston syringe is intended to inject or withdraw fluid from the neuraxial space with neuraxial specific connections. This product code may include epidural, peripheral, subarachnoid/spinal block, intrathecal and/or intracerebroventricular administration routes. The connector for neuraxial applications is...". As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- QEH
- Device name
- Piston Syringe With Neuraxial Connector – Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact
- FDA definition
- A neuraxial piston syringe is intended to inject or withdraw fluid from the neuraxial space with neuraxial specific connections. This product code may include epidural, peripheral, subarachnoid/spinal block, intrathecal and/or intracerebroventricular administration routes. The connector for neuraxial applications is intended to facilitate ANSI/AAMI/ISO 80369-6:2016 compliant neuraxial specific connections.
- Regulation
- 21 CFR 880.5860
- Device class
- Class II
- Review panel
- General Hospital
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 5
- Ingested recalls
- 0
Clearances, product code QEH
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2018 | 1 |
| 2020 | 2 |
| 2022 | 1 |
| 2024 | 1 |
Applicants with the most clearances
Product code QEH| Applicant | Clearances |
|---|---|
| Artiglass SRL | 1 |
| B.Braun Medical, Inc. | 1 |
| Becton Dickinson & Co | 1 |
| Intl. Medical Industries | 1 |
| Jiangsu Caina Medical Co., Ltd | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
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