Catheter, Transluminal Balloon
FDA 510(k) K781772 · Medi-Tech, Inc.
510(k) numberK781772
Submission
- Device name
- Catheter, Transluminal Balloon
- Applicant
- Medi-Tech, Inc.
Mchenry, IL, US - Received
- October 16, 1978
- Decision date
- March 6, 1979
- 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 |
| K781665 | Tube, Leatherman/ImbruceGBA · Traditional | National Catheter Co. Div. Mallinckrodt | 12/15/1978SE |
More from National Catheter Co. Div. Mallinckrodt
| 510(k) | Device | Decision |
|---|---|---|
| K954457 | Medi-Tech Eddy Intravascular Infusion CatheterKRA · Traditional | 05/15/1996SE |
| K952345 | Medi-Tech Platform Guide CatheterDQY · Traditional | 08/17/1995SE |
| K952056 | Immunoassay Drugs of Abuse ControlsDIF · Traditional | 06/01/1995SE |
| K945289 | Doa - Immunoassay Cut-Off CalibratorDKB · Traditional | 12/13/1994SE |
| K942551 | Therapeutic Drug Monitoring Control, AssayedDIF · Traditional | 10/06/1994SE |
| K943290 | Bilirubin Plus/Pediatric ControlsJJY · Traditional | 09/14/1994SE |
| K922990 | Hemodialysis BathKPO · Traditional | 09/12/1994SE |
| K942552 | Therapeutic Drug Monitoring Control, UnassayedDIF · Traditional | 09/09/1994SE |
| K904073 | Coagulation Reference Plasma, AbnormalGGC · Traditional | 10/22/1990SE |
| K895819 | Modified Labeling to the Spand-Gel Granulated GelKMF · Traditional | 11/02/1989SN |
Questions and answers
When was Catheter, Transluminal Balloon cleared by the FDA?
Catheter, Transluminal Balloon (K781772) received a 510(k) decision of Substantially Equivalent on March 6, 1979, 141 days after the submission was received.
What is the product code of K781772?
The FDA product code is GBA – Catheter, Balloon Type, a Class I (low risk) device regulated under 21 CFR 878.4200.