Automatic Pull Back Device
FDA 510(k) K933517 · Cardiovascular Imaging Systems, Inc.
510(k) numberK933517
Submission
- Device name
- Automatic Pull Back Device
- Applicant
- Cardiovascular Imaging Systems, Inc.
Sunnyvale, CA, US - Received
- July 20, 1993
- Decision date
- October 15, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQX – Wire, Guide, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1330
- Specialty
- Cardiovascular
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| K253667 | Accoat Guide WireDQX · Traditional | Sp Medical A/S | 07/14/2026SE |
| K261640 | Merit MAK Nitinol/Gold-Tungsten Guide WireDQX · Special | Merit Medical Ireland , Ltd. | 07/13/2026SE |
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| K260544 | FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD…DQX · Special | FMD Co., Ltd. | 03/20/2026SE |
| K253746 | Enroute 0.014'' Transcarotid GuidewireDQX · Special | Lake Region Medical | 03/19/2026SE |
| K253262 | EmeryGlide (EG18008901)DQX · Special | Nano4imaging GmbH | 03/06/2026SE |
| K253847 | Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)DQX · Special | Merit Medical Ireland, Ltd. | 01/31/2026SE |
| K251385 | InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire…DQX · Traditional | Merit Medical Ireland, Ltd. | 01/21/2026SE |
| K252674 | Solo Pace Fusion System (SOLOFUSE1)DQX · Traditional | Solo Pace, Inc. | 01/09/2026SE |
More from Solo Pace, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K970049 | BSC, Sonicath Ultra Imaging Catheter 3.2F/20MHZ(37410/456221 & BSC, Sonicath Ultra…ITX · Traditional | 06/20/1997SE |
| K942231 | Microview Ii/Microrail II CathetersDQO · Traditional | 08/01/1994SE |
| K930232 | Cvis Insight Imaging Guide CatheterDQO · Traditional | 07/21/1993SE |
| K924922 | Cvis Insight Imaging CatheterDQO · Traditional | 06/29/1993SE |
| K930311 | Cvis LongviewDQO · Traditional | 06/02/1993SE |
| K921879 | Cbis Catheter Pull-Back DeviceDQO · Traditional | 07/16/1992SE |
| K921750 | Cvis Insight III SystemITX · Traditional | 07/13/1992SE |
| K921631 | Cvis Insight Imaging Catheter for IntraluminalITX · Traditional | 07/02/1992SE |
| K921148 | Cvis Insight Catheters for Intracardiac UseITX · Traditional | 06/16/1992SE |
| K921147 | Cvis Insight Imaging Catheter for Intraluminal UseITX · Traditional | 06/16/1992SE |
Questions and answers
When was Automatic Pull Back Device cleared by the FDA?
Automatic Pull Back Device (K933517) received a 510(k) decision of Substantially Equivalent on October 15, 1993, 87 days after the submission was received.
What is the product code of K933517?
The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.