Identity
- Trade Name
- Sklar® FDA UDI
- Generic Name
- Intravascular occluding balloon catheter, image-guided FDA UDI
- Device Name
- STEINMANN PIN TROCR PT 9X4.0MM FDA UDI
- Model / Reference
- 40-1595 FDA UDI
- Description
- STEINMANN PIN TROCR PT 9X4.0MM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10649111083716 FDA UDI
- 510(k) Number
- K083912 FDA UDI
- FDA Product Code
- HTY FDA UDI
- GMDN Term
- Intravascular occluding balloon catheter, image-guided FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Intravascular occluding balloon catheter, image-guided
Sklar® by Sklar Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intravascular occluding balloon catheter, image-guided.
- HyperGlide — Micro Therapeutics, Inc. · Class II
- Q50 Plus — QXMedical, LLC · Class II
- Polyurethane Dual Lumen Occlusion Catheter — LeMaitre Vascular, Inc. · Class II
- BOBBY/SOFIA Kit — MICROVENTION INC. · Class II
- Pennig Minifixator — Orthofix, Inc. · Class II
- LMI BILUMEN IRRIGATION ARTERIAL EMBOLECTOMY CATHETER — LUCAS MEDICAL INC · Class II
- HyperFormTM — Micro Therapeutics, Inc. · Class II
- CELLO™, Balloon Guide Catheter — Fuji Systems Corp. · Class II
Cleared under the same submission
K083912 also covers:
- Sklar® — Sklar Corporation
- Sklar® — Sklar Corporation
- Sklar® — Sklar Corporation
- Sklar® — Sklar Corporation
- Sklar® — Sklar Corporation
- Sklar® — Sklar Corporation
- Sklar® — Sklar Corporation
- Sklar® — Sklar Corporation
- Sklar® — Sklar Corporation
- Sklar® — Sklar Corporation
- Sklar® — Sklar Corporation
- Sklar® — Sklar Corporation
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Sklar Corporation
Sources (1)
- FDA UDI 0f7a5f8d-d8da-40e5-ba76-cc38c2cd7ea9 34 fields · synced Jun 1, 2026