PARACENTESIS CATHETER DEVICE
FDA 510(k) clearance K974146 · decided 1998-01-28
Clearance details
- K-number
- K974146
- Device name
- PARACENTESIS CATHETER DEVICE
- Applicant
- Allegiance Healthcare Corp.
- Decision
- Substantially Equivalent
- Date received
- 1997-11-03
- Decision date
- 1998-01-28
- Days to decision
- 86 days
- Clearance type
- Traditional
- Product code
- GCB
- Device class
- 1
- Regulation number
- 878.4200
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Deerfield, IL, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
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| SUBCUTANEOUS TUNNELING NEEDLES & HANDLES (K854327) | Concord Laboratories, Inc. | 1985-11-13 |
| MANAN EPIDURAL NEEDLE (K852428) | Manan Manufacturing Co., Inc. | 1985-06-27 |
| NEEDLES, DESIGN CHANGE, IV CATHETERS (K780896) | Jelco Laboratories | 1978-08-23 |
Recalls involving this device
No recalls on record reference this clearance.