Thora-Drain III Plastic Drainage System
FDA 510(k) K801221 · Chesebrough-Pond'S U.S.A. Co.
510(k) numberK801221
Submission
- Device name
- Thora-Drain III Plastic Drainage System
- Applicant
- Chesebrough-Pond'S U.S.A. Co.
Mchenry, IL, US - Received
- May 22, 1980
- Decision date
- June 9, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KDQ – Bottle, Collection, Vacuum
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6740
- Specialty
- General Hospital
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| K984496 | Atrium Medical Corporation Express Chest DrainKDQ · Traditional | Atrium Medical Corp. | 05/05/1999SE |
| K962856 | Pleur-Evac Sahara Adult/Pediatric Chest Drainage System Model S-1100, S-1200, 2-2100…KDQ · Traditional | Deknatel, Inc. | 08/28/1996SE |
| K961287 | Rocket Pleuraseal II Chest Drainage SystemKDQ · Traditional | Rocket Medical Plc | 07/26/1996SE |
| K962168 | Mucus Specimen TrapKDQ · Traditional | Sage Products, Inc. | 07/22/1996SE |
| K950677 | Atrium Dry Suction Control Water Seal Chest DrainKDQ · Traditional | Atrium Medical Corp. | 04/13/1995SE |
| K941818 | PM9000 Vac TrapKDQ · Traditional | Precision Medical, Inc. | 12/12/1994SE |
| K932327 | Thora-Klex 350 ML Pediatric Chest Drainage SystemKDQ · Traditional | Davol, Inc. | 07/13/1993SE |
More from Davol, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K863866 | Respiradyne Ii(Tm)BZK · Traditional | 01/28/1987SE |
| K862803 | Chesebrough Pond's Hydrocolloid DressingFRO · Traditional | 11/14/1986SN |
| K851383 | Blisterfilm Transparent DressingNAD · Traditional | 07/05/1985SN |
| K851382 | Chesebrough-Pond's Sequential Wound DressingNAD · Traditional | 07/05/1985SN |
| K851539 | Chesebrough-Ponds Kangaroo Pump Set W/Easy-Cap CloKNT · Traditional | 06/12/1985SE |
| K843567 | Kangaroo Nasogastric Feeding TubeKNT · Traditional | 02/14/1985SE |
| K845010 | Chesebrough-Pond's Uri-Drain Male Urinary PouchEYQ · Traditional | 01/15/1985SE |
| K844186 | Continent Stoma System & AccessoriesKBG · Traditional | 01/15/1985SE |
| K844789 | Kangaroo Access II Enteral Feeding ContainerKNT · Traditional | 01/02/1985SE |
| K843128 | Female Urinary Incontinence SysKNX · Traditional | 01/02/1985SE |
Questions and answers
When was Thora-Drain III Plastic Drainage System cleared by the FDA?
Thora-Drain III Plastic Drainage System (K801221) received a 510(k) decision of Substantially Equivalent on June 9, 1980, 18 days after the submission was received.
What is the product code of K801221?
The FDA product code is KDQ – Bottle, Collection, Vacuum, a Class II (moderate risk) device regulated under 21 CFR 880.6740.