CAPD STAGED CONNECTOR
FDA 510(k) clearance K845041 · decided 1985-02-21
Clearance details
- K-number
- K845041
- Device name
- CAPD STAGED CONNECTOR
- Applicant
- Abbott Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1984-12-28
- Decision date
- 1985-02-21
- Days to decision
- 55 days
- Clearance type
- Traditional
- Product code
- FKO
- Device class
- 2
- Regulation number
- 876.5630
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Abbott Park, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CORPAK MEDSYSTEMS CRUZ CATHETER FOR PERITONEAL DIALYSIS (K964514) | Corpak, Inc. | 1998-06-26 |
| PERITONEAL DIALYSIS CATHETER CONNECTOR (K974570) | Medigroup, Inc. | 1998-02-27 |
| TITANIUM CONNECTOR (2 PART) (K910787) | Accurate Surgical Instruments Co. | 1991-08-15 |
| AMUKIN 50% - AIRSPRAY(R) (K885037) | Bernard J. Cooney, P.A. | 1990-10-19 |
| PERITONEAL DIALYSIS KIT (ACUTE AND CHRONIC FORM) (K874650) | Quinton, Inc. | 1987-12-09 |
| DIALY-NATE SET & DIALY-NATE CATHETER (K872221) | Gesco Intl., Inc. | 1987-10-13 |
| MODIFIED USE OF PULL-APART INTRODUCER SET (K871730) | Quinton, Inc. | 1987-05-18 |
| ACUTE PERITONEAL DIALYSIS KIT (K870472) | Quinton, Inc. | 1987-02-25 |
| PERITONEAL LAVAGE CATH PLC-8,SET PLS-8, KIT PLK-8 (K860155) | Medical Components, Inc. | 1986-02-14 |
| ACUTE PERITONEAL DIALYSIS CATHETERS (K854966) | Thermedics, Inc. | 1986-01-09 |
| LAZARUS-NELSON PERITONEAL LAVAGE TRAY (K813336) | American Pharmaseal Div. Ahsc | 1981-12-18 |
| NON-STERILE SHADOW-STRIPE CATHETER (K812717) | Quinton, Inc. | 1981-10-19 |
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 |
| ARCHITECT CORE-M / Alinity i Anti-HBc IgM (P060035/S043) | Abbott Laboratories | 2025-04-03 |
| 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 |