ABG POINT LOK NEEDLE PROTECTION DEVICE
FDA 510(k) clearance K954015 · decided 1995-11-20
Clearance details
- K-number
- K954015
- Device name
- ABG POINT LOK NEEDLE PROTECTION DEVICE
- Applicant
- Devon Industries, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-08-25
- Decision date
- 1995-11-20
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- CBT
- Device class
- 1
- Regulation number
- 868.1100
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Chatsworth, CA, US
- Third-party review
- No
- Expedited review
- No
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| VACVENT (K931873) | Steven Frank Mercereau | 1993-12-30 |
| BLOOD GAS KIT (NON-STERILE) REORDER NO. 0560 (K930986) | Customed, Inc. | 1993-07-14 |
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| 6 Fr Introducer Set, REF 21-2320-24 recall (Z-0858-04) | Deltec, Inc | 2004-07-20 |
| 9 Fr Introducer Set, REF 21-2340-24 recall (Z-0859-04) | Deltec, Inc | 2004-07-20 |
| 8.5 Fr Introducer Set, REF 21-2370-24 recall (Z-0860-04) | Deltec, Inc | 2004-07-20 |