510(k) K875016
- Device
- BIOSURGE MODEL ILVC-1
- Applicant
- BIOSURGE, INC.
- 510(k) number
- K875016
- Product code
- DWS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-02-29
- Date received
- 1987-12-04
- Regulation
- 870.4500
- Classification name
- Instruments, Surgical, Cardiovascular
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- LISA JOERGER
- Address
- 919 Westfall Rd., C-105 Rochester NY US 14618 14618
FDA Registration Numbers#
- 9617601
- 1423537
- 9614093
- 8010769
- 3032534
- 3011642792
- 2017865
- 9611262
- 3005809810
- 3036795921
- 1055890
- 2184009
- 1047843
- 1421101
- 3015895045
- 3021680161
- 1054241
- 2245304
- 1928237
- 2182208
- 9611278
- 9611273
- 3003696170
- 3011706110
- 8010273
- 3012434811
- 9611502
- 1220477
- 3010455030
- 3003761012
- 9611274
- 3003826419
- 3010055973
- 3010197700
- 8039053
- 1063481
- 8010300
- 8043467
- 1036836
- 3042278955
- 2126670
- 2084346
- 3003803182
- 3004961578
- 3005698350
- 1417485
- 9612030
- 1061124
- 3005440795
- 1935627
- 2134285
- 2320762
- 9611610
- 3003431869
- 3004215117
- 3029082594
- 2916714
- 9616538
- 3005528784
- 1424263
- 8010254
- 2434839
- 8010099
- 3015425104
- 1043729
- 3010052483
- 8040233
- 9612086
- 2183319
- 2249529
- 3003244954
- 9614062
- 9611617
- 2649622
- 3008902714
- 3007137643
- 3014579161
- 3007334784
- 3003882387
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 |
| 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 |
Legacy Summary#
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FDA Review#
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