510(k) K093257
- Device
- TORQMAX SHEATH GRIP ACCESSORY
- Applicant
- SPECTRANETICS CORP.
- 510(k) number
- K093257
- Product code
- OFC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-03-26
- Date received
- 2009-10-19
- Regulation
- 870.1340
- Classification name
- Catheter Introducer Kit
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- BRANDON HANSEN
- Address
- 9965 Federal Dr. Colorado Springs CO US 80921 80921
FDA Registration Numbers#
- 3026788751
- 9680794
- 3011137372
- 3012279212
- 1061124
- 3013666218
- 3008258694
- 3009756153
- 9681202
- 3003898360
- 1223004
- 3015859709
- 3004111573
- 1220477
- 3007284006
- 1643817
- 2030624
- 1423537
- 2134812
- 9616088
- 1724474
- 2245270
- 3007329020
- 3005704822
- 3009888344
- 3016112537
Source Documents#
Legacy Summary#
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FDA Review#
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