ATRION EPIDURAL ANESTHESIA KIT WITH ATRION NEEDLEVISE SHARPS SECURING SYSTEM
FDA 510(k) clearance K041158 · decided 2004-06-16
Clearance details
- K-number
- K041158
- Device name
- ATRION EPIDURAL ANESTHESIA KIT WITH ATRION NEEDLEVISE SHARPS SECURING SYSTEM
- Applicant
- Atrion Medical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-05-03
- Decision date
- 2004-06-16
- Days to decision
- 44 days
- Clearance type
- Traditional
- Product code
- CAZ
- Device class
- 2
- Regulation number
- 868.5140
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Arab, AL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| KESTREL NO. 695 HEATER (P820087/S011) | Atrion Medical Products, Inc. | 1988-06-17 |
| KESTREL NO. 695 HEATER (P820087/S009) | Atrion Medical Products, Inc. | 1988-01-19 |
| KESTREL NO. 695 HEATER (P820087/S008) | Atrion Medical Products, Inc. | 1987-11-27 |
| KESTREL NO. 695 HEATER (P820087/S010) | Atrion Medical Products, Inc. | 1987-10-30 |
| KESTREL NO. 695 HEATER (P820087/S007) | Atrion Medical Products, Inc. | 1987-09-09 |
| KESTREL NO. 695 HEATER (P820087/S006) | Atrion Medical Products, Inc. | 1986-07-07 |
| KESTREL NO. 695 HEATER (P820087/S005) | Atrion Medical Products, Inc. | 1986-07-07 |
| KESTREL NO. 695 HEATER (P820087/S004) | Atrion Medical Products, Inc. | 1985-11-18 |