California Medical Laboratories Inc. Standard and Small Rigid Tip Suction Wands

Q: What is the product code of K982891?

The FDA product code is DTS – Sucker, Cardiotomy Return, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4420.

FDA 510(k) K982891 · California Medical Laboratories, Inc.

Substantially Equivalent

510(k) numberK982891

Submission

Device name: California Medical Laboratories Inc. Standard and Small Rigid Tip Suction Wands
Applicant: California Medical Laboratories, Inc.
Irvine, CA, US
Received: August 17, 1998
Decision date: September 30, 1998
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: DTS – Sucker, Cardiotomy Return, Cardiopulmonary Bypass
Device class: Class II (moderate risk)
Regulation: 21 CFR 870.4420
Specialty: Cardiovascular

Other 510(k)s with product code DTS

510(k)	Device	Applicant	Decision
K053021	Estech Clearview MV Atrial DepressorDTS · Traditional	Estech, Inc.	01/26/2006SE
K963756	Ibc Cardiac Suction WardDTS · Traditional	International Biophysics Corp.	11/14/1997SE
K905008	Flexible Intracardiac Suction DeviceDTS · Traditional	Gish Biomedical, Inc.	01/23/1991SE
K900339	Hand-Held Intracardiac Suckers W/Ergonomic HandlesDTS · Traditional	Shiley, Inc.	03/28/1990SE
K891906	Robicsek Intracardiac Suction WandDTS · Traditional	Gish Biomedical, Inc.	06/13/1989SE
K801641	Ohio Disposable Clear Suction InstrumentDTS · Traditional	Ohio Medical Products	07/28/1980SE
K801400	Disposable Sucker SystemDTS · Traditional	Texas Medical Products, Inc.	06/30/1980SE
K791846	Dispossable Suction Tube, 6 FrenchDTS · Traditional	Dlp, Inc.	10/02/1979SE

More from Dlp, Inc.

510(k)	Device	Decision
K000830	Cannulation Tourniquet Set, 2 Tube or 5 TubeDWF · Traditional	09/07/2000SE
K993818	Antegrade/Retrograde Perfusion Adapter with or Without Pressure LineDWF · Traditional	02/08/2000SE

Questions and answers

When was California Medical Laboratories Inc. Standard and Small Rigid Tip Suction Wands cleared by the FDA?

California Medical Laboratories Inc. Standard and Small Rigid Tip Suction Wands (K982891) received a 510(k) decision of Substantially Equivalent on September 30, 1998, 44 days after the submission was received.

What is the product code of K982891?

The FDA product code is DTS – Sucker, Cardiotomy Return, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4420.