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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 26, 2007 | K071607 | ASA01 HEAVY DUTY SUCTION PUMP Zhongshan A&J Medical Equipment Co., Ltd., CN | BTA |
| Oct 4, 2006 | K062801 | SMARTSUCTION SOLO DEVICE Haemonetics Corp. | BTA |
| Sep 28, 2006 | K062610 | CARE-E-VAC 3 Ohio Medical Corporation | BTA |
| Jul 11, 2006 | K061133 | SIMEX SUCTION PUMP, MODELS AC20, AC20K, AC30, DC20, DC30 AND DC30S Novaspine, LLC | BTA |
| Jun 21, 2006 | K061205 | MEDELA VARIO 8/18/CI SECRETION & SURGICAL ASPIRATOR Medela AG, CH | BTA |
| Nov 4, 2005 | K052650 | PIONEER U601 SERIES ASPIRATOR Merits Health Products Co., Ltd., TW | BTA |
| Oct 5, 2005 | K052626 | SMARTSUCTION HARMONY DEVICE Haemonetics Corp. | BTA |
| Aug 17, 2005 | K051758 | PENUMBRA ASPIRATION PUMP, MODEL 115V Penumbra, Inc. | BTA |
| Jan 7, 2005 | K043544 | MEDELA DOMINANT 35 C/I SECRETION AND SURGICAL ASPIRATOR Medela AG, CH | BTA |
| Dec 17, 2004 | K042943 | NOUVAG AG - VACUSON 40 AND VACUSON 60 NOUVAG AG, CH | BTA |
| Sep 2, 2004 | K041405 | ASPIRATION PUMP, MODEL IMD-020 Industrial & Medical Design, Inc. | BTA |
| Jun 1, 2004 | K041199 | MEDI-PUMP ASPIRATOR, MODEL 1615 Thomas Industries | BTA |
| May 18, 2004 | K041154 | S-SCORT...JR QUICKDRAW, MODEL 2400 Sscor | BTA |
| Feb 17, 2004 | K040239 | SUPRAFLOW CONSOLE Neomedix Corp. | BTA |
| Oct 15, 2003 | K033179 | MEDELA CLARIO HOME CARE PUMP Medela AG, CH | BTA |
| May 15, 2002 | K021368 | MEDELA BASIC 30 AND DOMINANT 50 SUCTION PUMPS, MODELS 037, 057 Medela AG, CH | BTA |
| Jan 28, 2002 | K013585 | MEDIPORT 2000 MOBILE Servox Medizintechnik GmbH, DE | BTA |
| Jan 18, 2002 | K013116 | DURQ/ QUALIDURA Ever-Safety Technical Service, CN | BTA |
| Jun 8, 2001 | K011601 | ARDO SUCTION PUMP MASTER, MODEL 30.00.XX; ARDO SUCTION PUMP SENATOR, MODEL 31.00.XX Ardo Medical AG, CH | BTA |
| Dec 20, 1999 | K993668 | LAERDAL SUCTION UNIT,(4000) MODEL 78 00 20 Laerdal Medical A/S, NO | BTA |
| Sep 23, 1999 | K992026 | SORING GMBH, SONOCA 300 Soring GmbH Medizintechnik | BTA |
| Feb 26, 1999 | K984363 | XPS TISSUE ASPIRATION SYSTEM, XPS STRAIGHTSHOT OR MODEL 2000 MICRODEBRIDER SYSTEM Xomed, Inc. | BTA |
| Feb 12, 1999 | K982371 | MEDCO ASPIRATOR IV Medco Mfg. | BTA |
| Jan 7, 1999 | K983552 | BASIC, MEDIAN, DOMINANT, AND VARIO Medela, Inc. | BTA |
| Aug 12, 1998 | K981703 | KSEA UNIMAT 45 Karl Storz Endoscopy | BTA |
| Jul 17, 1998 | K981602 | DEVILBISS MODEL 6305D HEAVY DUTY AC ASPIRATOR Sunrise Medical Hhg, Inc. | BTA |
| Apr 1, 1998 | K971749 | EASYGO ASPIRATOR Precision Medical, Inc. | BTA |
| Mar 24, 1998 | K980301 | IP-16 Servizi Medico Estetici Italinai Srl. | BTA |
| Mar 18, 1998 | K980454 | LYSONIX ASPIRATION PUMP Lysonix, Inc. | BTA |
| Mar 5, 1998 | K980392 | PSI-TEC ASPIRATOR Byron Medical | BTA |
| Nov 26, 1997 | K973268 | MICROAIRE POWER ASPIRATION DEVICE PAD SYSTEM Microaire Surgical Instruments, Inc. | BTA |
| Jun 5, 1997 | K971107 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER STR5 Alexander Mfg. Co. | BTA |
| Mar 26, 1997 | K963775 | MODEL 8800 ASPIRATOR Medical Specifics, Inc. | BTA |
| Mar 5, 1997 | K964997 | S-SCORT (2500) Sscor | BTA |
| Mar 4, 1997 | K965059 | CPI, MAXI-VAC(6480),THOMAS INDUSTRIES, MEDI-PUMP(1240/1242/1243) Thomas Industries | BTA |
| Feb 14, 1997 | K970186 | GI SUPPLY PARACENTESIS PUMP Gi Supply | BTA |
| Dec 23, 1996 | K960492 | SI CONTROLLER MODEL SI 500 I.C Medical, Inc. | BTA |
| Nov 29, 1995 | K954287 | ACI FINE NEEDLE ASPIRATION BIOPSY KIT Advanced Cytometrix, Inc. | BTA |
| Nov 29, 1995 | K954286 | ACI PULSATING VACUUM PUMP SYSTEM Advanced Cytometrix, Inc. | BTA |
| Nov 29, 1995 | K954264 | ACI SINGLE LUMEN BIOPSY NEEDLE Advanced Cytometrix, Inc. | BTA |
| Oct 26, 1995 | K952806 | MEDI PUMP ASPIRATOR MODELS 1130 AND 1135 Thomas Industries | BTA |
| Aug 23, 1995 | K953132 | UIMAT PUMP KARL STORZ Endoscopy-America, Inc. | BTA |
| Aug 21, 1995 | K951729 | MEDI - PUMP Thomas Industries | BTA |
| Jul 31, 1995 | K952103 | AEROS ASPIRATOR Aeros Instruments, Inc. | BTA |
| Jun 16, 1995 | K952632 | S-SCORT Sscor | BTA |
| May 15, 1995 | K951326 | BIOPSY DEVICE ACCESSORY Biopsys Medical, Inc. | BTA |
| May 9, 1995 | K950495 | SUGICAL DYNAMICS ENDOSCOPY IRRIGATION PUMP, CATALOG #3-4000 Surgical Dynamics, Inc. | BTA |
| May 5, 1995 | K932031 | AMBU PORTABLE SUCTION UNIT Ambu, Inc. | BTA |
| Apr 18, 1995 | K951423 | ASPIRATOR, CONTINUOUS & PROGRAMMABLE INTERMITTENT Impact Instrumentation, Inc. | BTA |
| Mar 2, 1995 | K941961 | 605 VACU-MAX Medical Industries America, Inc. | BTA |
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