Panels › General, Plastic Surgery › Product code BTA · Class 2
Pump, Portable, Aspiration (Manual Or Powered)
Regulation 878.4780
7510(k)s in 12 months (160 all time)
0recalls in 12 months (21 all time)
16recalls that name a 510(k)
Top companies in BTA
| Company | 510(k)s | Recalls |
|---|---|---|
| Medela AG | 10 | 0 |
| Ohio Medical Corporation | 2 | 5 |
| S S C O R Inc | 0 | 6 |
| Aeros Instruments, Inc. | 5 | 0 |
| Egnell, Inc. | 5 | 0 |
| Precision Medical, Inc. | 3 | 2 |
| Thomas Industries | 5 | 0 |
| Sscor | 4 | 0 |
| Advanced Cytometrix, Inc. | 3 | 0 |
| Haemonetics Corp. | 2 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 20, 2023 | R A Medical Services MINISCAV (tm) Vacuum Pump Open, Classified |
BTA | K160950 |
| Nov 16, 2021 | Ohio Medical Corporation Instavac Portable Suction Pump, Constant mode (model #757000, Instavac C) and Intermittent mode (model 756000, Instavac I); and Instavac replacement pumps, part #AI5511, a component of model numbers 7 Open, Classified |
BTA | K933902 |
| Dec 2, 2020 | Medela AG Medical Technology Stryker Medela REF 077.0193 AXS Universal Aspiration Tubing (01)07612367053921 - Product Usage: AXS Universal Aspiration Tubing is used with the Dominant Flex Surgical Suction Pump. Terminated |
BTA | K170329 |
| Sep 7, 2018 | Ohio Medical Corporation Portable Suction Pump, (a) Style 758010, Model CARE-E-VAC 3, Ohio Medical LLC; (b) Style 758000, Model CARE-E-VAC 3, Ohio Medical LLC
The care-e-(R)3 is a portable medical aspirator used to suction Terminated |
BTA | K062610 |
| Feb 8, 2016 | MicroAire Surgical Instruments, LLC MicroAire PAL-R4011XL - 40cm x 4 mm Del Vecchio French Rasp aspiration cannula Terminated |
BTA | K973268 |
| Dec 29, 2010 | Ohio Medical Corporation Care E Vac 3 Portable Suction; Battery/AC Portable Aspirator; Ohio Medical Corporation, 1111 Lakeside Drive, Gurnee, IL 60031; Model 758000
The device is a portable aspirator to help evacuate saliva, Terminated |
BTA | K062610 |
| Jun 7, 2010 | Ohio Medical Corporation NPWT Small Mobile Bag No Logo; an adjunct to the MoblVac Portable Wound Care Pump; Ohio Medical Corporation, 1111 Lakeside Drive, Gurnee, IL 60031; Model 769709. Terminated |
BTA | K081185 |
| Jun 7, 2010 | Ohio Medical Corporation MoblVac Portable Wound Care Pump; an AC/DC powered portable aspirator that provides negative pressure for the application of wound drainage; Ohio Medical Corporation, Gurnee, IL 60031; Models 769600 ( Terminated |
BTA | K081185 |
| Oct 27, 2008 | Smith And Nephew, Inc. Wound Management Division GlobTek, Inc. Power Supply for Medical Use Part No: TR9CE4000LCP-Y-MED MODEL: GTM21097-5012, Made in China.
Indicated for patients who would benefit from a suction device particularly as the device m Terminated |
BTA | K042134 |
| Sep 29, 2008 | Neomedix Corp NeoMedix Trabectome I/A Console, Model Number 550014, surgical aspirator Terminated |
BTA | K040239 |
| Sep 4, 2008 | Medtronic Neuromodulation Suction Jar Lid for Medela Vario 18 Vacuum Pump used with the Bravo pH Monitoring System Medtronic Part Number: 9043K2101. (9043K2111 is the OUS version) The Vacuum Pump is used to provide the vacuum Terminated |
BTA | K061205 |
| Aug 6, 2008 | Smith And Nephew, Inc. Wound Management Division FLAT DRAIN -10MM, CHARIKER-JETER DRESSING KITS (LARGE AND SMALL) -Product numbers 6680217 and 6680221 - Wound Management Product.
Indicated for patients who wold benefit from a suction device particul Terminated |
BTA | K042134 |
| Oct 12, 2006 | Haemonetics Corporation SmartSuction Harmony Powered Suction Device
Model Number: HAR-E-115-US Terminated |
BTA | K052626 |
| Jan 27, 2005 | S S C O R Inc SSCOR Suction Device Model 2315 Terminated |
BTA | None listed |
| Jan 27, 2005 | S S C O R Inc SSCOR Suction Device Model 2314B Terminated |
BTA | None listed |
| Jan 27, 2005 | S S C O R Inc SSCOR Suction Device Model 2314 Terminated |
BTA | None listed |
| Jan 27, 2005 | S S C O R Inc SSCOR Suction Device Model 2310BV-230 Terminated |
BTA | None listed |
| Jan 27, 2005 | S S C O R Inc SSCOR Suction Device Model 2310V Terminated |
BTA | None listed |
| Jan 27, 2005 | S S C O R Inc SSCOR Suction Device Model 2310BV Terminated |
BTA | K945929 |
| Dec 15, 2004 | Precision Medical, Inc. Easy Go Vac Aspirator, Model PM65HG. Portable suction unit Terminated |
BTA | K971749 |
| Dec 15, 2004 | Precision Medical, Inc. Easy Go Vac Aspirator, Model PM65. Portable suction unit Terminated |
BTA | K971749 |
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