Balloon Retention Chest Catheter
FDA 510(k) K802025 · Loseff Medical Designers, Ltd.
510(k) numberK802025
Submission
- Device name
- Balloon Retention Chest Catheter
- Applicant
- Loseff Medical Designers, Ltd.
Mchenry, IL, US - Received
- August 20, 1980
- Decision date
- September 26, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GBA – Catheter, Balloon Type
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4200
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GBA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K861877 | Byron Word Bartholian Gland CatheterGBA · Traditional | Byron Medical | 05/30/1986SE |
| K790444 | Elecath Multi-Purpose Arterial SurgerGBA · Traditional | Electro-Catheter Corp. | 06/11/1979SE |
| K781772 | Catheter, Transluminal BalloonGBA · Traditional | Medi-Tech, Inc. | 03/06/1979SE |
| K781665 | Tube, Leatherman/ImbruceGBA · Traditional | National Catheter Co. Div. Mallinckrodt | 12/15/1978SE |
More from National Catheter Co. Div. Mallinckrodt
| 510(k) | Device | Decision |
|---|---|---|
| K801349 | Loseff Balloon Type Self-Retention WoundJCX · Traditional | 08/07/1980SE |
Questions and answers
When was Balloon Retention Chest Catheter cleared by the FDA?
Balloon Retention Chest Catheter (K802025) received a 510(k) decision of Substantially Equivalent on September 26, 1980, 37 days after the submission was received.
What is the product code of K802025?
The FDA product code is GBA – Catheter, Balloon Type, a Class I (low risk) device regulated under 21 CFR 878.4200.