510(k) K841468
- Device
- PMA ANGIOGRAPHY TRAY
- Applicant
- PROFESSIONAL MEDICAL SERVICES
- 510(k) number
- K841468
- Product code
- DWS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-06-05
- Date received
- 1984-04-09
- 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#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 9611814
- 3005593675
- 3006950086
- 3011137372
- 1721504
- 9611112
- 1058726
- 3006897899
- 3003322138
- 3010699884
- 3008902714
- 1519227
- 2015691
- 9611827
- 2320762
- 1720929
- 1723241
- 3013784566
- 1649914
- 3004001706
- 8010099
- 2522007
- 3008770252
- 1625519
- 8043895
- 9680718
- 3008998256
- 3017636737
- 3042940336
- 3004605321
- 1423537
- 3013846070
- 1450662
- 3003675041
- 1412854
- 8043496
- 9614062
- 3004111573
- 1055236
- 2011171
- 3008592544
- 9680519
- 3013938829
- 9611503
- 3015970743
- 1061124
- 1649833
- 3012267976
- 3009763019
- 1417592
- 1935627
- 3012434811
- 3048101437
- 8043548
- 1319660
- 3017540705
- 3014201171
- 2182208
- 3012448339
- 1056350
- 3010055973
- 1063481
- 3007507973
- 3011636272
- 3015225571
- 2029275
- 9611273
- 8010168
- 8010769
- 3022862651
- 8044098
- 1000165971
- 3013497507
- 3033589330
- 9617601
- 3011706110
- 9613083
- 3012226300
- 3035708926
- 9616088
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 |
| 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 |
Legacy Summary#
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FDA Review#
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