LIFECARE CONT. EPIDURAL CATH. FOR MORPHINE SULFATE
FDA 510(k) clearance K893766 · decided 1989-11-01
Clearance details
- K-number
- K893766
- Device name
- LIFECARE CONT. EPIDURAL CATH. FOR MORPHINE SULFATE
- Applicant
- Abbott Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1989-05-19
- Decision date
- 1989-11-01
- Days to decision
- 166 days
- Clearance type
- Traditional
- Product code
- MAJ
- Device class
- 2
- Regulation number
- 868.5120
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Abbott Park, IL, US
- Third-party review
- No
- Expedited review
- No
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| MEDTRONIC ALGOLINE INTRASPINAL CATHETER SYSTEM (K965251) | Medtronic Vascular | 1997-03-18 |
| MEDTRONIC MODEL 3864C & 3865C TEMPORARY SCREENING LEAD/CATHETER KIT (K945413) | Medtronic Vascular | 1995-05-24 |
| TEMPORARY SCREENING LEAD/ CATHETER KIT (K934939) | Medtronic Vascular | 1995-05-24 |
| SUBCUTANEOUS TUNNELING NEEDLE AND HANDLES (K930218) | Concord/Portex | 1993-07-27 |
| IPI ALGO-LINE CATHETER (K911382) | Pudenz-Schulte Medical Research Corp. | 1991-07-18 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ARCHITECT CORE / Alinity i Anti-HBc (P080023/S046) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT AFP / Alinity i AFP (P120008/S030) | Abbott Laboratories | 2025-04-03 |
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| ARCHITECT Total PSA / Alinity i Total PSA (P910007/S066) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT Free PSA / Alinity i Free PSA (P980007/S055) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Qualitative/Qualitative Confirmatory / Alinity i HBsAg Qualitative II/Qualitative II Confirmatory (P110029/S052) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Next Qualitative / ARCHITECT HBsAg Next Confirmatory/ Alinity i HBsAg Next Qualitative/Alinity i HBsAg N (P210003/S013) | Abbott Laboratories | 2025-04-03 |
| ARCHITECT HBsAg Next Qualitative/Next Confirmatory, Alinity i HBsAg Next Qualitative/Next Confirmatory (P210003/S012) | Abbott Laboratories | 2024-09-30 |