510(k) K962771
- Device
- BURKE CONGENITAL THORACOSCOPY INSTRUMENTS
- Applicant
- PILLING WECK, INC.
- 510(k) number
- K962771
- Product code
- DWS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-11-19
- Date received
- 1996-07-16
- Regulation
- 870.4500
- Classification name
- Instruments, Surgical, Cardiovascular
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- RICHARD G JONES
- Address
- 420 Delaware Dr. Fort Washington PA US 19034 19034
FDA Registration Numbers#
- 3012434811
- 3005593675
- 3003882387
- 8043404
- 8044098
- 3005809810
- 3015451162
- 9613079
- 3014201171
- 3009703496
- 8043769
- 3010202439
- 8010269
- 1649395
- 1123137
- 9611112
- 3011175548
- 3014579161
- 3042278955
- 2020394
- 1055890
- 3003675041
- 2184009
- 1226015
- 3035678069
- 1060680
- 1721504
- 9611610
- 9680519
- 1640201
- 3029082594
- 9615005
- 1055236
- 1519227
- 9617604
- 3017636737
- 1319660
- 1223651
- 9617601
- 8010591
- 3003322138
- 3009959868
- 1721251
- 3012448339
- 3004001706
- 1935627
- 3010162973
- 2522007
- 8010099
- 3004608878
- 9611502
- 3013784566
- 2242352
- 3009763019
- 3005182241
- 3002862271
- 1423537
- 2133928
- 5906
- 2183570
- 3007334784
- 9611278
- 2029275
- 3035708926
- 1220648
- 8043548
- 1921846
- 1723241
- 2518902
- 8040233
- 3014334038
- 3008770252
- 3015398570
- 2183744
- 1319639
- 3006950086
- 1061124
- 1625519
- 3016408131
- 9616250
Source Documents#
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 |
| 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 |
| K960143 | G.E. STERILE DIGITAL ANGIOGRAPHIC TRAY | GE Medical Systems | 1996-04-09 |
| 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 |
| K893436 | MODIFIED STERILIZATION METHOD OF PTI HEART-LIFT | Pioneering Technologies, Inc. | 1989-07-14 |
| K892804 | NEWCHILL(TM) CARDIAC INSULATOR | Acacia Laboratories, 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 |
Legacy Summary#
summary
FDA Review#
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