Tube, Leatherman/Imbruce
FDA 510(k) K781665 · National Catheter Co. Div. Mallinckrodt
510(k) numberK781665
Submission
- Device name
- Tube, Leatherman/Imbruce
- Applicant
- National Catheter Co. Div. Mallinckrodt
Mchenry, IL, US - Received
- September 28, 1978
- Decision date
- December 15, 1978
- 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 |
| K802025 | Balloon Retention Chest CatheterGBA · Traditional | Loseff Medical Designers, Ltd. | 09/26/1980SE |
| K790444 | Elecath Multi-Purpose Arterial SurgerGBA · Traditional | Electro-Catheter Corp. | 06/11/1979SE |
| K781772 | Catheter, Transluminal BalloonGBA · Traditional | Medi-Tech, Inc. | 03/06/1979SE |
More from Medi-Tech, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K802918 | Anthron Catheter SetFOZ · Traditional | 04/21/1981SE |
| K802505 | Double Lumen Tracheal TubeBTR · Traditional | 03/13/1981SE |
| K810321 | Reinforced Tracheostomy Tube Set(Tentat)BTO · Traditional | 03/04/1981SE |
| K801924 | Hi-Lo Temp Gen. Purpose Temp. ProbeFLL · Traditional | 09/09/1980SE |
| K801005 | MLT Tube Microlaryngeal Tracheal Tube)BTR · Traditional | 05/23/1980SE |
| K791190 | Stethoscope with Temperature SensorBZT · Traditional | 07/06/1979SE |
| K770727 | Manipulator & Injector, UterineKNA · Traditional | 04/26/1977SE |
Questions and answers
When was Tube, Leatherman/Imbruce cleared by the FDA?
Tube, Leatherman/Imbruce (K781665) received a 510(k) decision of Substantially Equivalent on December 15, 1978, 78 days after the submission was received.
What is the product code of K781665?
The FDA product code is GBA – Catheter, Balloon Type, a Class I (low risk) device regulated under 21 CFR 878.4200.