Ackrad Esophageal Balloon Catheter Set
FDA 510(k) K952542 · Ackrad Laboratories
510(k) numberK952542
Submission
- Device name
- Ackrad Esophageal Balloon Catheter Set
- Applicant
- Ackrad Laboratories
Cranford, NJ, US - Received
- May 23, 1995
- Decision date
- April 23, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- BZC – Calculator, Pulmonary Function Data
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1880
- Specialty
- Anesthesiology
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| K181524 | Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART…BZC · Traditional | Vyaire Medical, Inc. | 11/30/2018SE |
| K162515 | COSMED K5 Wearable Metabolic TechnologyBZC · Traditional | Cosmed Srl | 06/20/2017SE |
| K161295 | MiniBox +BZC · Traditional | Pulmone Advanced Medical Devices, Ltd. | 10/21/2016SE |
| K150810 | Vyntus / SentrySuite Product LineBZC · Traditional | Carefusion Germany 234 GmbH | 08/14/2015SE |
| K133925 | Vyntus/ Sentrysuite Product LineBZC · Traditional | Carefusion Germany 234 GmbH | 08/22/2014SE |
| K133051 | Pulmone Minibox PFT TMBZC · Traditional | Pulmone Advanced Medical Devices, Ltd. | 05/02/2014SE |
| K102047 | Lci Option for InnocorBZC · Traditional | Innovision A/S | 11/01/2011SE |
More from Innovision A/S
| 510(k) | Device | Decision |
|---|---|---|
| K021272 | Sib Catheter, Model 61-7005LKF · Special | 05/21/2002SE |
| K020954 | H/S Procedure Tray (5F), H/S Procedure Tray (7F), H/S Elliptosphere Procedure Tray &…LKF · Special | 04/24/2002SE |
| K020951 | H/S Catheter Set (5F), Model 61-5005; H/S Catheter Set (7F), Model 61-5007LKF · Special | 04/16/2002SE |
| K970492 | Intrauterine Insemination and Sonohysterography CatheterLKF · Traditional | 04/09/1997SE |
| K961752 | H/S Catheter SET(61-3005, 61-3007, 61-3605, 61-3607)LKF · Traditional | 08/08/1996SE |
| K940176 | Ackrad Iui Set for Intrauterine InseminationMFD · Traditional | 04/23/1996SE |
| K953034 | H/S Catheter SET(61-3005, 61-3007, 61-3605, 61-3607)LKF · Traditional | 08/29/1995SE |
| K915813 | Ackrad Ercp Contrast Delivery SetFGE · Traditional | 03/11/1992SE |
| K904499 | Nicos (Non-Invasive Cardiac Output System)KFG · Traditional | 07/01/1991SE |
| K911780 | Infant Nasal Cannulae Assembly, ModifiedBZD · Traditional | 06/24/1991SE |
Questions and answers
When was Ackrad Esophageal Balloon Catheter Set cleared by the FDA?
Ackrad Esophageal Balloon Catheter Set (K952542) received a 510(k) decision of Substantially Equivalent on April 23, 1996, 336 days after the submission was received.
What is the product code of K952542?
The FDA product code is BZC – Calculator, Pulmonary Function Data, a Class II (moderate risk) device regulated under 21 CFR 868.1880.