Stockert Compact System
FDA 510(k) K982014 · Stoeckert Instrumente
510(k) numberK982014
Submission
- Device name
- Stockert Compact System
- Applicant
- Stoeckert Instrumente
North Attleboro, MA, US - Received
- June 8, 1998
- Decision date
- September 4, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DTQ – Console, Heart-Lung Machine, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4220
- Specialty
- Cardiovascular
- Life-sustaining
- Yes
Other 510(k)s with product code DTQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K232291 | Essenz HLM, Essenz ILBMDTQ · Special | Livanova Deutschland, GmbH | 08/24/2023SE |
| K221895 | Terumo Advanced Perfusion System 1DTQ · Traditional | Terumo Cardiovascular Systems Corporation | 04/18/2023SE |
| K221373 | Essenz HLMDTQ · Traditional | Livanova Deutschland, GmbH | 03/09/2023SE |
| K210130 | Stockert S5 SystemDTQ · Special | Livanova Deutschland, GmbH | 04/05/2021SE |
| K202125 | Century Perfusion SystemDTQ · Traditional | Century Hlm, LLC | 03/07/2021SE |
| K190282 | Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand)DTQ · Traditional | Spectrum Medical , Ltd. | 05/24/2019SE |
| K173834 | Quantum Pump ConsoleDTQ · Traditional | Spectrum Medical , Ltd. | 05/25/2018SE |
| K172220 | Advanced Perfusion System 1DTQ · Special | Terumo Cardiovascular Systems Corporation | 08/17/2017SE |
| K163531 | Advanced Perfusion System 1DTQ · Traditional | Terumo Cardiovascular Systems Corporation | 06/07/2017SE |
| K153376 | Advanced Perfusion System 1DTQ · Special | Terumo Cardiovascular Systems Corporation | 12/16/2015SE |
More from Terumo Cardiovascular Systems Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K002273 | Stockert A272 Series Pediatric Aortic CannulaeDWF · Abbreviated | 01/29/2001SE |
| K001961 | Stockert A242 and A252 Series Arterial Femoral CannulaeDWF · Abbreviated | 01/25/2001SE |
| K002118 | Stockert Compact System Version 2.0DTQ · Special | 08/09/2000SE |
| K992635 | Interface Module IdddKRI · Special | 12/20/1999SE |
| K990512 | Stockert Power Supply Unit for S3 ComponentsKRI · Traditional | 11/23/1999SE |
| K972321 | S3 Mast PumpDWB · Traditional | 02/27/1998SE |
| K971520 | S3 Cyclic RPM ControlDWB · Traditional | 09/10/1997SE |
| K962320 | S3 Cardioplegia ControlDTR · Traditional | 01/10/1997SE |
| K955152 | Stockert S3 Ups, LVL CTRL Bubb. Det., Dual Press. Ctrl., Temp Mont., TimerDTW · Traditional | 02/22/1996SE |
| K955038 | Stockert S3 Double Head Pump ModuleDWB · Traditional | 02/21/1996SE |
Questions and answers
When was Stockert Compact System cleared by the FDA?
Stockert Compact System (K982014) received a 510(k) decision of Substantially Equivalent on September 4, 1998, 88 days after the submission was received.
What is the product code of K982014?
The FDA product code is DTQ – Console, Heart-Lung Machine, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4220.