510(k) K850105
- Device
- KM PRODUCTS ASPIRATING TUBING
- Applicant
- KM PRODUCTS
- 510(k) number
- K850105
- Product code
- BSY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-03-21
- Date received
- 1985-01-11
- Regulation
- 868.6810
- Classification name
- Catheters, Suction, Tracheobronchial
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- ALAN R KENT
- Address
- 1349 W. Allegheny Tucson AZ US 85705 85705
FDA Registration Numbers
- 3008264111
- 9680661
- 3015173212
- 1423537
- 3034602341
- 9614093
- 2029275
- 3011987967
- 3003674698
- 3003786160
- 3004134948
- 3013576541
- 3016458361
- 3009747810
- 1216677
- 3034669683
- 3005621808
- 3012480535
- 3013530405
- 3010400865
- 3010822231
- 3034629649
- 3030726486
- 8022978
- 3006897996
- 3008395508
- 3038632675
- 3003717263
- 3005980667
- 3035451914
- 3036979319
- 3011237770
- 9680518
- 1220850
- 3015997711
- 1420054
- 9617604
- 1062154
- 9681848
- 3018366470
- 3010202439
- 2032112
- 2529776
- 9616088
- 3018094310
- 3036893546
- 2011171
- 3010889742
- 8030673
- 3013404794
- 3014544429
- 3013412170
- 1319639
- 3011529314
- 3016758972
- 3032327991
- 1018233
- 3005418739
- 3007441619
- 8021995
- 1123010
- 3003528228
- 3015337348
- 3016452400
- 3029917416
- 3009540516
- 3011052946
- 3003915875
- 9680411
- 3008846950
- 3016763307
- 3020188747
- 3008729892
- 3012445205
- 3006606984
- 9611665
- 3013188547
- 3004519921
- 1220477
Source Documents
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code BSY
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K031997 | MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTEM | Mallinckrodt Dar S.R.L. | 2003-11-25 |
| K992902 | AMBU HAND POWER SUCTION PUMP | Ambu, Inc. | 1999-10-25 |
| K982945 | DUAL PURPOSE CLOSED CATHETER | Spirit Medical Systems, Inc. | 1998-09-22 |
| K981910 | SUCTION CATHETER | Ni-Med, Inc. | 1998-08-24 |
| K972258 | HI-CARE CLOSED SUCTION SYSTEM | Mallinckrodt Medical | 1997-12-29 |
| K973199 | AMSINO SUCTION CATHETER | Amsino Intl., Inc. | 1997-09-10 |
| K961707 | TRACH-EZE CLOSED VENTILATION SUCTION SYSTEM | Sorenson Critical Care | 1997-03-11 |
| K964369 | TRACH CARE SET WITH MICROBAN | Ballard Medical Products | 1997-02-11 |
| K960488 | NEO 2 LINE SUCTION SYSTEM | Alcove Medical, Inc. | 1996-04-26 |
| K955831 | ARGYLE ASPR-CARE CLOSED SUCTION SYSTEM | Sherwood Medical Co. | 1996-03-28 |
| K955645 | CATH-GUIDE | Hudson Respiratory Care, Inc. | 1996-03-12 |
| K952396 | REDI NURSE SYSTEM (RNS) STERILE 0.9% SODIUM CHLORIDE SOLUTION | Contour Fabricators of Florida, Inc. | 1995-08-15 |
| K952395 | REDI NURSE SYSTEM (RNS) STERILE WATER FOR IRRIGATION | Contour Fabricators of Florida, Inc. | 1995-08-15 |
| K953226 | PULM O2 SUCTION CATHETER TRAYS | Premium Plastics, Inc. | 1995-08-08 |
| K951506 | SUCTION CATHETER KIT, STERILE, SINGLE-USE | Trinity Laboratories, Inc. | 1995-07-03 |
Legacy Summary
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FDA Review
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