Elecath Multi-Purpose Arterial Surger
FDA 510(k) K790444 · Electro-Catheter Corp.
510(k) numberK790444
Submission
- Device name
- Elecath Multi-Purpose Arterial Surger
- Applicant
- Electro-Catheter Corp.
Mchenry, IL, US - Received
- March 6, 1979
- Decision date
- June 11, 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 |
| 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 |
|---|---|---|
| K934785 | MultipaceLDF · Traditional | 07/27/1995SE |
| K943257 | Tip Deflector (Genesis)DRF · Traditional | 04/19/1995SE |
| K933451 | Open Tip Multi-Electrode Catheter, ModificationDRF · Traditional | 04/19/1995SE |
| K933450 | Closed Tip Multi-Electrode Catheter, ModificationDRF · Traditional | 04/19/1995SE |
| K934787 | Silicore Semi-FloaterLDF · Traditional | 02/24/1995SE |
| K874154 | Elecath(R) Transesophageal Pacing CatheterKNT · Traditional | 04/29/1988SE |
| K854511 | Elecath Percutaneous Left Atrial Cannulation SetDQX · Traditional | 02/10/1986SE |
| K854975 | Elecath Pulsatile Perfusion PumpKFM · Traditional | 01/15/1986SE |
| K850065 | Elecath Torkfloat Pacing ProbeDTB · Traditional | 04/10/1985SE |
| K850324 | Elecath Open Tip Bipolar Pacing CatheterLDF · Traditional | 03/27/1985SE |
Questions and answers
When was Elecath Multi-Purpose Arterial Surger cleared by the FDA?
Elecath Multi-Purpose Arterial Surger (K790444) received a 510(k) decision of Substantially Equivalent on June 11, 1979, 97 days after the submission was received.
What is the product code of K790444?
The FDA product code is GBA – Catheter, Balloon Type, a Class I (low risk) device regulated under 21 CFR 878.4200.