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FDA 510(k)

AUTOMATIC PULL BACK DEVICE

K-Number: K933517 · 1993-10-15

ApplicantCardiovascular Imaging Systems, Inc.
Decision Date1993-10-15
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AUTOMATIC PULL BACK DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Cardiovascular Imaging Systems, Inc.. It received FDA 510(k) clearance on 1993-10-15 under 510(k) number K933517. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTOMATIC PULL BACK DEVICE?

AUTOMATIC PULL BACK DEVICE is a medical device that received FDA 510(k) clearance on 1993-10-15. The listed applicant is Cardiovascular Imaging Systems, Inc.. The 510(k) number is K933517.

When did AUTOMATIC PULL BACK DEVICE receive FDA 510(k) clearance?

AUTOMATIC PULL BACK DEVICE received FDA 510(k) clearance on 1993-10-15, under 510(k) number K933517.

Who is the listed applicant for AUTOMATIC PULL BACK DEVICE?

The FDA 510(k) record lists Cardiovascular Imaging Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AUTOMATIC PULL BACK DEVICE?

The FDA product code for AUTOMATIC PULL BACK DEVICE is DQX.

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Other records listing Cardiovascular Imaging Systems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K970049BSC, SONICATH ULTRA IMAGING CATHETER 3.2F/20MHZ(37410/456221 & BSC, SONICATH ULTRA IMAGING CATHETER 2.9F/20MHZ/37411/K942231MICROVIEW II/MICRORAIL II CATHETERSK930232CVIS INSIGHT IMAGING GUIDE CATHETERK924922CVIS INSIGHT IMAGING CATHETERK930311CVIS LONGVIEWK921879CBIS CATHETER PULL-BACK DEVICE

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Related Devices (Code: DQX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253146Hyperdrive 35 GuidewireRapid-Medical , Ltd.K261281CROSSLEAD Standard 035 and CROSSLEAD Stiff 035Filmecc Co., Ltd.K253667Accoat Guide WireSp Medical A/SK261640Merit MAK Nitinol/Gold-Tungsten Guide WireMerit Medical Ireland , Ltd.K254137InQwire Amplatz Guide WireMerit Medical Ireland, Ltd.K260544FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40FMD Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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