Shockwave CS Guide Catheter
Shockwave Medical, Inc. · Cardiovascular
Open FDA's page for this record- Third party flag
- N
- City
- Santa Clara
- Advisory committee description
- Cardiovascular
- Address 1
- 5403 Betsy Ross Dr.
- Statement or summary
- Summary
- Product code
- DQY
- Zip code
- 95054
- Applicant
- Shockwave Medical, Inc.
- Decision date
- 2025-05-02
- Decision code
- SESE
- Country code
- US
- Device name
- Shockwave CS Guide Catheter
- Advisory committee
- CV
- Contact
- Renee Maack
- K number
- K243757
- State
- CA
- Date received
- 2024-12-06
- Review advisory committee
- CV
- Postal code
- 95054
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Catheter, Percutaneous
- Medical specialty description
- Cardiovascular
- Regulation number
- 870.1250
- Device class
- 2
- Registration number
- 3004784537, 3013557562, 3014498720, 3006425876, 9710641, 2953200, 3013162291, 3010291427, 8010026, 3033589330, 3015615738, 2134265, 1319639, 2032112, 1828132, 2182208, 1000121056, 1118880, 1220477, 3005334138, 3009051888, 3020677060, 3008264254, 3001374820, 3014644549, 3013758550, 1721686, 3012543881, 3017708755, 3021951050, 3008789872, 3014461810, 3003955307, 3010370269, 3015225571, 9616666, 9680794, 3006451981, 1220452, 3014779787 +238 more
- FEI number
- 3004784537, 3013557562, 3014498720, 3002913962, 3006425876, 3003094851, 3013162291, 3010291427, 3033589330, 3015615738, 2828, 1828132, 2182208, 1000121056, 1118880, 1220477, 3005747797, 3003528016, 3005334138, 3009051888, 3020677060, 3008264254, 3001374820, 3014644549, 3013758550, 1721686, 3012543881, 3017708755, 3021951050, 3008789872, 3014461810, 3003955307, 3010370269, 3015225571, 3006451981, 1220452, 3014779787, 3005580113, 1000138054, 3020954746 +237 more