IRRIGATION SYRINGE KIT
FDA 510(k) clearance K982435 · decided 1998-11-06
Clearance details
- K-number
- K982435
- Device name
- IRRIGATION SYRINGE KIT
- Applicant
- Sub-Q, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-07-13
- Decision date
- 1998-11-06
- Days to decision
- 116 days
- Clearance type
- Traditional
- Product code
- KYZ
- Device class
- 1
- Regulation number
- 880.6960
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- San Clemente, CA, US
- Third-party review
- No
- Expedited review
- No
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| QS DELIVERY SYSTEM (K991254) | Sub-Q, Inc. | 1999-08-23 |
| ZEROWET SPLASHIELD (K974288) | Zerowet, Inc. | 1998-01-29 |
| RMI DUAL FLUID IRRIGATING SYRINGE (K964833) | Research Medical, Inc. | 1997-02-19 |
| MARPP PRESSURE MONITORING SYSTEM (K960725) | Paradigm Medical, Inc. | 1996-07-15 |
| CPR IRRIGATION TRAY (K960212) | Custom Pack Reliability | 1996-04-01 |
| REDI NURSE SYSTEM (RNS) PRE-FILLED 60CC IRRIGATION SYRINGE W/STERILE SODIUM CHLORIDE SOLUTION (K952406) | Contour Fabricators of Florida, Inc. | 1995-08-07 |
| REDI NURSE SYSTEM (RNS) PRE-FILLED 10CC, 30CC, 60CC SYRINGE W/STERILE WATER (K952407) | Contour Fabricators of Florida, Inc. | 1995-08-07 |
| INMAN IRRIGATION TAPERED PROBE (K933171) | Inman Medical Corp. | 1994-04-29 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| SURESTAT ARTERIAL CLOSURE SYSTEM (P010049/S012) | Sub-Q, Inc. | 2004-08-31 |
| QUICKSEAL SURESTAT ARTERIAL CLOSURE SYSTEM (P010049/S011) | Sub-Q, Inc. | 2004-07-01 |
| QUICKSEAL SURESHOT ARTERIAL CLOSURE SYSTEM (P010049/S010) | Sub-Q, Inc. | 2004-05-25 |
| QUICKSEAL CONTROL FEMORAL ARTERIAL CLOSURE SYSTEM (P010049/S009) | Sub-Q, Inc. | 2003-12-23 |
| QUICKSEAL CONTROL ARTERIAL CLOSURE SYSTEM (P010049/S008) | Sub-Q, Inc. | 2003-08-13 |
| QUICKSEAL II ARTERIAL CLOSURE SYSTEM (P010049/S006) | Sub-Q, Inc. | 2003-04-24 |
| QUICKSEAL CCS ARTERIAL CLOSURE SYSTEM (P010049/S005) | Sub-Q, Inc. | 2003-03-12 |
| QUICKSEAL II ARTERIAL CLOSURE SYSTEM (P010049/S004) | Sub-Q, Inc. | 2003-02-10 |