FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NEW USCI 7F PTCA GUIDING CATHETER
K Number: K905249
·
Decision Feb 19, 1991
Classifications
1
FEI Numbers
276
Registration Numbers
277
Same Product Code
889
Applicant Total
645
Review Days
90
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- NEW USCI 7F PTCA GUIDING CATHETER
- K Number
- K905249
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- C.R. Bard, Inc.
- Date Received
- November 21, 1990
- Decision Date
- February 19, 1991
- Product Code
- DQY
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DQY | Catheter, Percutaneous | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DQY), ordered by most recent decision date.
Amplatzer TorqVue Exchange System
FDA 510(k)
FDA Class 2
·Cardiovascular
Perfect-O Ostial Positioning Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Amplatzer TorqVue Delivery System
FDA 510(k)
FDA Class 2
·Cardiovascular
Teleport Glide Microcatheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Amplatzer Trevisio Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80
FDA 510(k)
FDA Class 2
·Cardiovascular
C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48)
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by C.R. Bard, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K254076 | BD Touchless Plus Unisex Pre-Lubricated Urethral Catheter Kit | May 29, 2026 | Unknown |
| K252971 | Elyra Thulium Fiber Laser System and Elyra Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories) | Mar 17, 2026 | Substantially Equivalent |
| K251864 | Rubber Utility Catheter | Feb 23, 2026 | Substantially Equivalent |
| K251186 | Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer) | May 15, 2025 | Substantially Equivalent |
| K241334 | Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 5Fr. (006225P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 6Fr. (006241P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 7Fr. (006242P); NBIH Temporary Pacing Electrode Catheter, | Jan 31, 2025 | Substantially Equivalent |
| K230356 | Aspirex Thrombectomy System | Mar 31, 2023 | Substantially Equivalent |
| K223177 | Highlander 014 PTA Balloon Dilatation Catheter | Jan 20, 2023 | Substantially Equivalent |
| K222793 | WavelinQ Generator | Oct 17, 2022 | Substantially Equivalent |
| K220270 | Aspirex Thrombectomy System | Jun 21, 2022 | Substantially Equivalent |
| K213203 | Provena(TM) Midline Catheter | May 13, 2022 | Substantially Equivalent |