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FDA 510(k)

RAULERSON ONE-STEP GUIDEWIRE INSERTION BULB NEEDLE

K-Number: K971281 · 1997-10-09

ApplicantMedcomp
Decision Date1997-10-09
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RAULERSON ONE-STEP GUIDEWIRE INSERTION BULB NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Medcomp. It received FDA 510(k) clearance on 1997-10-09 under 510(k) number K971281. 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 RAULERSON ONE-STEP GUIDEWIRE INSERTION BULB NEEDLE?

RAULERSON ONE-STEP GUIDEWIRE INSERTION BULB NEEDLE is a medical device that received FDA 510(k) clearance on 1997-10-09. The listed applicant is Medcomp. The 510(k) number is K971281.

When did RAULERSON ONE-STEP GUIDEWIRE INSERTION BULB NEEDLE receive FDA 510(k) clearance?

RAULERSON ONE-STEP GUIDEWIRE INSERTION BULB NEEDLE received FDA 510(k) clearance on 1997-10-09, under 510(k) number K971281.

Who is the listed applicant for RAULERSON ONE-STEP GUIDEWIRE INSERTION BULB NEEDLE?

The FDA 510(k) record lists Medcomp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RAULERSON ONE-STEP GUIDEWIRE INSERTION BULB NEEDLE?

The FDA product code for RAULERSON ONE-STEP GUIDEWIRE INSERTION BULB NEEDLE is DQX.

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Other records listing Medcomp 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.

K123292T3K1029662.6F X 20CM VASCU-PICC, 2.6F X 50CM VASCU-PICCK091954MICRO-STICK SETK091953PRO-PICCK092347PRO-PICC CTK090394VALVED TEARWAY INTRODUCER

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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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