510(k) K843216
- Device
- Eclipse Heart Support For Coronary Arter
- Applicant
- BIOTRAC LABORATORIES
- 510(k) number
- K843216
- Product code
- GAD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-09-20
- Date received
- 1984-08-15
- Regulation
- 878.4800
- Classification name
- Retractor
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3021477808
- 3009051471
- 2030599
- 3006765019
- 3021519357
- 3004499989
- 3010197239
- 3042235752
- 1526534
- 3042255021
- 3003882387
- 1315756
- 3021985829
- 8043404
- 3003694247
- 8044098
- 3009865268
- 3043355002
- 3005809810
- 3030626857
- 3012234585
- 3005641619
- 3007024186
- 2183449
- 3015451162
- 9613079
- 3014201171
- 9611390
- 8043769
- 3010202439
- 8043746
- 9611112
- 3008114965
- 3002808270
- 3018240684
- 3001620590
- 8010935
- 1055890
- 3003675041
- 3005827567
- 1038671
- 3009513193
- 3005751028
- 2184009
- 3003587896
- 2431453
- 3003435550
- 3011767135
- 3016807211
- 3035678069
- 9617297
- 8010523
- 3009468807
- 3008693678
- 3030861184
- 9611610
- 8010890
- 9680519
- 3002090132
- 3013011598
- 3038503932
- 3023155873
- 9681129
- 9680735
- 3013503739
- 2511556
- 2436906
- 1828288
- 9613350
- 8010343
- 3029082594
- 3043521642
- 3011689956
- 3014207283
- 3002907620
- 3010123206
- 3009882462
- 3007366790
- 9612075
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GAD#
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|---|---|---|---|
| K152538 | JRP Wound Spreader | J.R. Parker, LLC | 2016-04-13 |
| K151104 | OTELO LL | Spineart | 2016-01-06 |
| K132645 | THORATRAK MICS RETRACTOR SYSTEM, RACK, BLADES | Medtronic, Inc. | 2013-10-04 |
| K071775 | DASH | Ezsurgical | 2007-08-07 |
| K050256 | APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTOR | Apple Medical Corp. | 2005-04-26 |
| K043602 | QUADRANT RETRACTOR SYSTEM | Medtronic Sofamor Danek | 2005-02-23 |
| K001339 | MRI FASTSYSTEM RETRACTOR SYSTEM | Omni-Tract Surgical, Div. Minn. Scientific, Inc. | 2000-05-17 |
| K980588 | CLARUS ENDOSCOPIC DISCECTOMY SYSTEM SITETRAC MODEL 6000 | Clarus Medical Systems, Inc. | 1998-08-18 |
| K963006 | SCION SAPHENOUS VEIN HARVESTING SYSTEM | Scion International, Inc. | 1996-09-20 |
| K943875 | VILLALTA RETRACTOR | Hct, Inc. | 1994-11-09 |
| K942002 | RETRACTOR | Automated Medical Products Corp. | 1994-05-17 |
| K941448 | RETRACTOR | Technovations | 1994-04-15 |
| K930316 | LUNG RETRACTORS: DAVIDSON, SEMB | Thomasville Medical Assoc. | 1994-02-10 |
| K926585 | THOROCOSCOPY SELF-RETAINING RETRACTOR | T. Korossurgical Instruments Corp. | 1993-08-06 |
| K921020 | HARGIS SELF RETRACTION SYSTEM | Medin Corp. | 1993-07-02 |