FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SUBCLAVIAN, GISH MODEL NO. SVAC-XXXX
K Number: K863791
·
Decision Jun 25, 1987
Classifications
1
FEI Numbers
276
Registration Numbers
277
Same Product Code
889
Applicant Total
75
Review Days
272
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- SUBCLAVIAN, GISH MODEL NO. SVAC-XXXX
- K Number
- K863791
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Gish Biomedical, Inc.
- Date Received
- September 26, 1986
- Decision Date
- June 25, 1987
- Product Code
- DQY
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DQY | Catheter, Percutaneous | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DQY), ordered by most recent decision date.
Amplatzer TorqVue Exchange System
FDA 510(k)
FDA Class 2
·Cardiovascular
Perfect-O Ostial Positioning Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Amplatzer TorqVue Delivery System
FDA 510(k)
FDA Class 2
·Cardiovascular
Teleport Glide Microcatheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Amplatzer Trevisio Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80
FDA 510(k)
FDA Class 2
·Cardiovascular
C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48)
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Gish Biomedical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K090449 | MEDOS HILITE INFANT OXYGENATOR, MODEL 1000, 800 LT | Sep 18, 2009 | Substantially Equivalent |
| K090450 | MEDOS HILITE PEDIATRIC OXYGENATOR, MODELS 2800, 2400 LT | Sep 18, 2009 | Substantially Equivalent |
| K091062 | MEDOS HILITE INFANT RESERVOIR, MODEL MVC 0730 | Aug 4, 2009 | Substantially Equivalent |
| K083131 | MEDOS HILITE RESERVOIR, MODEL: 4030 | Jul 30, 2009 | Substantially Equivalent |
| K082403 | MEDOS HILITE OXYGENATOR, MODEL 7000 & 7000 LT | May 15, 2009 | Substantially Equivalent |
| K082082 | GISH SVR SOFT VENOUS RESERVOIRS WITH HA COATING | Feb 4, 2009 | Substantially Equivalent |
| K081947 | GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH HA COATING | Feb 4, 2009 | Substantially Equivalent |
| K080708 | VISION HOLLOW FIBER OXYGENATOR WITH HA COATING | Feb 2, 2009 | Substantially Equivalent |
| K081838 | GISH VISION BLOOD CARDIOPLEGIA WITH HA COATING | Jan 26, 2009 | Substantially Equivalent |
| K081881 | GISH TUBING AND CONNECTORS WITH HA COATING | Jan 23, 2009 | Substantially Equivalent |