SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)
Pressure Products Medical Device Manufacturing, LLC · Cardiovascular
Open FDA's page for this record- Third party flag
- N
- City
- Morton
- Advisory committee description
- Cardiovascular
- Address 1
- 1 School St.
- Statement or summary
- Summary
- Product code
- DRC
- Zip code
- 19070
- Applicant
- Pressure Products Medical Device Manufacturing, LLC
- Decision date
- 2024-05-17
- Decision code
- SESE
- Country code
- US
- Device name
- SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)
- Advisory committee
- CV
- Contact
- Andrew Armour
- K number
- K241042
- State
- PA
- Date received
- 2024-04-17
- Review advisory committee
- CV
- Postal code
- 19070
- Decision description
- Substantially Equivalent
- Clearance type
- Special
- Harmonized identifiers (openFDA)
- Device name
- Trocar
- Medical specialty description
- Cardiovascular
- Regulation number
- 870.1390
- Device class
- 2
- Registration number
- 3030446844, 9616088, 3013388519, 1000523114, 2029015, 3013400708, 3009605245, 8039051, 3016248634, 1061124, 3005334138, 3003528228, 3004111573, 3011600579, 3033589330, 3011137372, 3015972835, 2246552, 1625425, 1319211, 1921846, 3045058049, 3007361214, 3003882387, 1018470, 3027815, 3030733800, 1820334, 3009393076, 3015225571, 1058584, 3016950436, 1222313, 3010273872, 1836564, 3023191945, 2640138, 1216677, 3015976667, 3010200163 +55 more
- FEI number
- 3030446844, 1000160458, 3013388519, 1000523114, 3013400708, 3009605245, 3016248634, 2523865, 3005334138, 3003528228, 3004111573, 3011600579, 3033589330, 3000206435, 3015972835, 3001236905, 5638, 2246552, 1625425, 1319211, 1921846, 3003370911, 3045058049, 3007361214, 3003882387, 1018470, 3030733800, 3003094851, 1820334, 3009393076, 3015225571, 3016950436, 3002806934, 3010273872, 3023191945, 1216677, 3015976667, 3010200163, 2022435, 3003877407 +55 more