Product code DTS
- Device name
- Sucker, Cardiotomy Return, Cardiopulmonary Bypass
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.4420
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K053021 | ESTECH CLEARVIEW MV ATRIAL DEPRESSOR | Estech, Inc. | 2006-01-26 |
| K982891 | CALIFORNIA MEDICAL LABORATORIES INC. STANDARD AND SMALL RIGID TIP SUCTION WANDS | California Medical Laboratories, Inc. | 1998-09-30 |
| K963756 | IBC CARDIAC SUCTION WARD | International Biophysics Corp. | 1997-11-14 |
| K905008 | FLEXIBLE INTRACARDIAC SUCTION DEVICE | Gish Biomedical, Inc. | 1991-01-23 |
| K900339 | HAND-HELD INTRACARDIAC SUCKERS W/ERGONOMIC HANDLES | Shiley, Inc. | 1990-03-28 |
| K891906 | ROBICSEK INTRACARDIAC SUCTION WAND | Gish Biomedical, Inc. | 1989-06-13 |
| K801641 | OHIO DISPOSABLE CLEAR SUCTION INSTRUMENT | Ohio Medical Products | 1980-07-28 |
| K801400 | DISPOSABLE SUCKER SYSTEM | Texas Medical Products, Inc. | 1980-06-30 |
| K791846 | DISPOSSABLE SUCTION TUBE, 6 FRENCH | Dlp, Inc. | 1979-10-02 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08033178018746 | Suction tip | SORIN GROUP ITALIA SRL | 2024-04-04 |
| 08033178018739 | Suction tip | SORIN GROUP ITALIA SRL | 2024-04-04 |
| 08033178018647 | Suction tip | SORIN GROUP ITALIA SRL | 2024-04-04 |
| 08033178018654 | Suction tip | SORIN GROUP ITALIA SRL | 2024-04-04 |
| 08033178018661 | Suction tip | SORIN GROUP ITALIA SRL | 2024-04-04 |
| 08033178018678 | Suction tip | SORIN GROUP ITALIA SRL | 2024-04-04 |
| 08033178018708 | Suction tip | SORIN GROUP ITALIA SRL | 2024-04-04 |
| 08033178018715 | Suction tip | SORIN GROUP ITALIA SRL | 2024-04-04 |
| 08033178018722 | Suction tip | SORIN GROUP ITALIA SRL | 2024-04-04 |
| 08033178018753 | Suction tip | SORIN GROUP ITALIA SRL | 2024-03-20 |
| B0662010360000 | Pediatric Grooved Tip Sucker | NOVOSCI CORP. | 2016-09-26 |
| B0662010350000 | ADULT GROOVED TIP SUCKER | NOVOSCI CORP. | 2016-09-26 |
| B0662010370000 | INFANT GROOVED TIP SUCKER | NOVOSCI CORP. | 2016-09-26 |
| B0662010900000 | ADULT SUMP SUCKER | NOVOSCI CORP. | 2016-09-26 |
| B0662011350000 | HEX HANDLE GROOVED TIP SUCKER | NOVOSCI CORP. | 2016-09-26 |
| B0662011640000 | HEX HANDLE DEBRIDEMENT SUCKER | NOVOSCI CORP. | 2016-09-26 |
| 08033178004480 | Intracardiac Sucker | SORIN GROUP ITALIA SRL | 2016-03-21 |
| 08033178004701 | Intracardiac Sucker | SORIN GROUP ITALIA SRL | 2016-03-21 |
| 08033178004695 | Intracardiac Sucker | SORIN GROUP ITALIA SRL | 2016-03-21 |
| 08033178004497 | Intracardiac Sucker | SORIN GROUP ITALIA SRL | 2016-03-21 |
| 08033178004466 | Intracardiac Sucker | SORIN GROUP ITALIA SRL | 2016-03-21 |
| B066201035NS1 | ADULT GROOVED TIP SUCKER | NOVOSCI CORP. | 2015-10-13 |
| B066201036NS1 | PEDIATRIC GROOVED TIP SUCKER | NOVOSCI CORP. | 2015-10-13 |
| B066201037NS1 | INFANT SUCKER GROOVED TIP | NOVOSCI CORP. | 2015-10-13 |
| B066201080NS1 | ADULT TIP SUCKER | NOVOSCI CORP. | 2015-10-13 |
| B066201090NS1 | ADULT SUMP SUCKER | NOVOSCI CORP. | 2015-10-13 |
| B066201164NS1 | ADULT DEBRIDEMENT SUCKER HEX HANDLE | NOVOSCI CORP. | 2015-10-13 |
| B0662010800000 | TIP SUCKER | NOVOSCI CORP. | 2015-10-09 |
| B0662010830000 | INFANCT SUMP SUCKER | NOVOSCI CORP. | 2015-10-09 |
| B0662010640000 | DEBRIDEMENT SUCKER | NOVOSCI CORP. | 2015-10-06 |