510(k) K960143
- Device
- G.e. Sterile Digital Angiographic Tray
- Applicant
- GE MEDICAL SYSTEMS
- 510(k) number
- K960143
- Product code
- DWS
- Decision
- Unknown (SESK)
- Decision date
- 1996-04-09
- Date received
- 1996-01-16
- Regulation
- 870.4500
- Classification name
- Instruments, Surgical, Cardiovascular
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- PATRICK J LAMB
- Address
- 1247 Flordia Ave. Palm Harbor FL US 34683 34683
FDA Registration Numbers#
- 3003244954
- 1720747
- 1063481
- 8010273
- 1416666
- 8043496
- 8043404
- 3031231776
- 3004111573
- 3010455030
- 3033589330
- 3009703496
- 9611503
- 2434839
- 3043543260
- 3042278955
- 2025816
- 3008595179
- 3010197700
- 8040233
- 3003882387
- 8010422
- 9611617
- 8010528
- 8010877
- 1220648
- 3049552730
- 3033536312
- 3014615697
- 1036836
- 3012507533
- 3013288201
- 1421101
- 3003687489
- 3011111237
- 3015309643
- 1530504
- 2030624
- 3005809810
- 1043214
- 1640201
- 8010395
- 1424478
- 1412854
- 1047843
- 3010407203
- 1000393132
- 1646747
- 1423537
- 3005528784
- 3008500478
- 9616227
- 9680518
- 2029275
- 3010687973
- 3006554912
- 1056350
- 1724474
- 1054241
- 1424263
- 3014579161
- 1421879
- 1649833
- 9680515
- 3006897899
- 9610621
- 2020550
- 9680519
- 8010704
- 8022210
- 8010168
- 3013938829
- 1928237
- 3019455
- 8039053
- 8010235
- 1649139
- 3008592544
- 9610612
- 9616246
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DWS#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K022238 | MYOCARDIAL LEAD IMPLANT TOOL, MODEL 10626 | Medtronic Vascular | 2002-10-09 |
| K964445 | OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006) | Dlp, Inc. | 1997-01-30 |
| K962771 | BURKE CONGENITAL THORACOSCOPY INSTRUMENTS | Pilling Weck, Inc. | 1996-11-19 |
| K955689 | RNS STERILE, DISPOSABLE DIGITAL ANGIOGRAPHIC TRAY | Contour Fabricators of Florida, Inc. | 1996-05-15 |
| K960139 | G.E. STERILE ANGIOGRAPHIC TRAY | GE Medical Systems | 1996-04-19 |
| K960144 | G.E. STERILE CT BIOPSY TRAY | GE Medical Systems | 1996-04-15 |
| K934727 | REPLACEMENT PARTS FOR CPI 6888 LEAD TUNNELER | Cardiac Pacemakers, Inc. | 1994-01-10 |
| K900379 | HYCULT DIAMOND CORONARY BYPASS KNIFE | St. Jude Medical, Inc. | 1990-03-19 |
| K896307 | INSULATION PAD | Bio-Vascular, Inc. | 1990-01-19 |
| K894738 | MODEL 6888 LEAD TUNNELER | Cardiac Pacemakers, Inc. | 1989-09-13 |
| K892804 | NEWCHILL(TM) CARDIAC INSULATOR | Acacia Laboratories, Inc. | 1989-07-14 |
| K893436 | MODIFIED STERILIZATION METHOD OF PTI HEART-LIFT | Pioneering Technologies, Inc. | 1989-07-14 |
| K891000 | MODIFIED EXTERNAL PAD | Instromedix, Inc. | 1989-05-19 |
| K890432 | DEKNATEL HIGH PRECISION VASCULAR PUNCH(TM) | Deknatel, Inc. | 1989-04-13 |
| K890707 | PHRENIC NERVE PAD & NERVE PAD W/1/4 PERCARDIAL | Dlp, Inc. | 1989-04-10 |