pilot TLS
Vygon Corporation · General Hospital
Open FDA's page for this record- Third party flag
- N
- City
- Lansdale Montgomery
- Advisory committee description
- General Hospital
- Address 1
- 2750 Morris Rd.
- Address 2
- Suite A200
- Statement or summary
- Summary
- Product code
- LJS
- Zip code
- 19446
- Applicant
- Vygon Corporation
- Decision date
- 2025-02-26
- Decision code
- SESE
- Country code
- US
- Device name
- pilot TLS
- Advisory committee
- HO
- Contact
- Chris Steinke
- K number
- K241587
- State
- PA
- Date received
- 2024-06-03
- Review advisory committee
- CV
- Postal code
- 19446
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
- Medical specialty description
- General Hospital
- Regulation number
- 880.5970
- Device class
- 2
- Registration number
- 3010882708, 3018094310, 2527072, 1000484830, 3016472589, 9617592, 1061124, 3006425876, 3030714660, 3035111606, 1722746, 3004111573, 3013233645, 3011137372, 3033589330, 3006260740, 2246552, 3007697249, 1625425, 9680794, 3013666218, 1319211, 3015537049, 3011237770, 1921846, 3015060216, 3016727301, 3008236846, 3006942602, 3010827261, 1820334, 3015225571, 1833566, 3013750125, 2133772, 1319639, 1000314502, 1018233, 3038181770, 1721676 +48 more
- FEI number
- 3010882708, 3018094310, 2527072, 3001237338, 1000484830, 3016472589, 1000120555, 1000115408, 3006425876, 3030714660, 3035111606, 3932, 3004111573, 3013233645, 3033589330, 3000206435, 3001236905, 3006260740, 2246552, 3000209794, 3007697249, 1625425, 1000138054, 3013666218, 1319211, 3015537049, 3011237770, 1921846, 3015060216, 3016727301, 3008236846, 3006942602, 3010827261, 3003737899, 3003094851, 1820334, 3015225571, 3013750125, 1000306139, 3006097687 +48 more