STOCKERT-SHILEY CAPS AND CAPS DUAL PRESSURE MODULE
FDA 510(k) clearance K862836 · decided 1986-09-12
Clearance details
- K-number
- K862836
- Device name
- STOCKERT-SHILEY CAPS AND CAPS DUAL PRESSURE MODULE
- Applicant
- Shiley, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-07-25
- Decision date
- 1986-09-12
- Days to decision
- 49 days
- Clearance type
- Traditional
- Product code
- DXS
- Device class
- 2
- Regulation number
- 870.4310
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Irvine, CA, 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 |
|---|---|---|
| PRESSURE DISPLAY BOX,DLP DISPOSABLE PRESSURE DISPLAY SETS-NON STERILE VERSIONS (K113235) | Medtronic, Inc. | 2011-12-02 |
| VTI DISPOSABLE PRESSURE DISPLAY SET (K944764) | Vascular Technology Incorporated | 1994-12-27 |
| TMP PRESSURE ISOLATORR, TMP PRESSURE MONITOR SYST (K912045) | Lifestream Int'L, Inc. | 1991-10-31 |
| STOCKERT SHILEY DUAL PRESSURE CONTROL MODULE XR (K900797) | Shiley, Inc. | 1990-05-10 |
| PRESSURE BARRIER KIT CAT. NO. PBK-3 (K873802) | American Omni Medical, Inc. | 1987-11-06 |
| PRESSURE DISPLAY BOX #60000/TUBING SET #61000 (K852232) | Dlp, Inc. | 1985-08-09 |
| PRESSURE MONITOR (K842194) | Norton Texas Medical Products | 1984-08-27 |
| PM-3 (K831750) | Delta Medical Industries | 1983-07-26 |
| GAMBRO PRESSURE MONITOR PRM 10 (K822822) | Gambro, Inc. | 1982-10-18 |
| PMS-2 PRESSURE MONITOR SEPARATOR (K820912) | Delta Medical Industries | 1982-05-18 |
| CHAMBER, MC-1 DISPOSABLE PRESSURE (K781890) | Delta Medical Industries | 1978-12-04 |
| CORONARY PRESSURE PERFUSION PUMP (K771764) | 3M Health Care, Sarns | 1977-09-30 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| BJORK-SHILEY CARDIAC VALVE (P780008/S013) | Shiley, Inc. | 1986-10-31 |
| BJORK-SHILEY CARDIAC VALVE (P780008/S014) | Shiley, Inc. | 1985-04-09 |
| BJORK-SHILEY CARDIAC VALVE (P780008/S015) | Shiley, Inc. | 1984-11-26 |
| BJORK-SHILEY CARDIAC VALVE (P780008/S011) | Shiley, Inc. | 1984-05-15 |
| BJORK-SHILEY CARDIAC VALVE (P780008/S007) | Shiley, Inc. | 1983-05-20 |
| BJORK-SHILEY CARDIAC VALVE (P780008/S005) | Shiley, Inc. | 1982-02-05 |